Document 1126436

October7,2005
WestemInstitutional Review Board
3535 7ti Ave. SW
. Olympia, WA 98502
Review Item: Public Consultation and PubIic Disclosure Activities
Sponsor: Northfield Laboratories,Inc.
ProtocolNR: RTBSE-1l- (N)
ReviewedItem: POLY SFH-P
WlRB PR NR: 20030927/1066482
PI: Carl Rosati, MD
Surg. Crit. Care Med. MC-162
47 New ScotlandAve.
Albany, NY 12208
Study Coordinator: SusanRauch,RN
Pul. Div. Crit. CareMed. MC-91
47 New ScotlandAve.
Albany, NY 12208
Phone: 5 1S-262-6608
5 18-262-3661
Fax:
[email protected]
a
Protocol NR
: RTBSE-1 l-(N)
WIRB PR NR
: 20030927
Sponsor
: Northfield Laboratories, Inc.
Drug
: POLY SFII-P
PI
: Carl Rosati, MD
Surg. Crit. Care Med. MC-162
47 New Scotland Ave.
Albany, NY 12208
Study Coordinator : Susan Rauch, RN
518-262-6608
Public Consultation and Public Disclosure Activities
September12,200:5
Prior to the PressReleasescheduledfor September7’, our public relations dFpartm.ent
notified a numberof public official of the study andplannedpublic consultation. Smce
Albany is the statecapital, our PR Departmentwishesto allow severalweeks to allow
them to voice any questionsor concerns.We receivedno contact fiorn our local political
figures. Listed be’Lowarethoseto whom notificatioh was sent.
Name
nator Neil Breslin
ty Exedve. MichaelBrealii
Address
Community Out Research Process
1) PressConference - September7,2005
2) SaratogaCommunity Meeting- September12,2005
with distribution of information brochuresin Saratogaand Skidmore
College.
.
3) Albany Medical Center CommunityMeeting - September14,2005
4) Empire StatePlaza Concourse- September15,20,26, and 27,2005
5) Colonie Family Day - September17,2005
6) Nursing Education TeachingDay - September18,2005
7) The SchohauieHealth Fair - September21,2005
8) Albany Medical Center Community’Meeting- October 5,2005
9) Website- Live September7,2005 and will continue through study.
10) Study Phone Line -5 18-262-2828
11) Local Colle:ges-I have also contactedseverallocal collegesin the hope of getting
information on the student’sweb site with a link to the Polyhemesite.
Unfortunately, only one collegewas willing to permit it. Pleasesee attached
cmails.
12) Public shopping areas
. A brochure on the bulletin board in someof our larger grocery storeswas
permitted.
9 I also attemptedto have an information table in both of our largestmalls and
was denied. Not even allowed to leavebrochures!
. Some local businessdid allow me to leave small batchesof informational
brochures(subway& starbucks).
13) PolyhemeQuestion & Answer Brochures- Used them at every event and
distributed approximately 1000.
14) Letters sent to every Jehovah’sWitnessesCongregation (10) in the TriCity area.
The PI and Study Coordinatormet the Hospital Liaison Committee for Jehovah’s
Witnesses.
The majority of responsesthat we receivedcamefrom personalcontact either through a
communitymeeting or an information table.
Media Coverage
September 7,, 2005 ‘- Press Conference
J-J
.
. WNYT
’ WTJZN
n
POX Capital News 9
9 WRGBI
. WXXAI
Newspaper
n
Business Review
. Troy Record
. Times Union
. Dailey Gazette
. Saratogian
Radio
. WGY
. WAMC
. NPR
AMC Commanity Meetings g/14/05 & 10/05/05
Newspapers
.
.
8
.
.
.
9
Times Union
Gazette
Troy Record
Post Star
Saratogian
Spotlights
Jewish World
Albanv Medical Center Publications
m The Page
m Groupw:ise email system (Community Meetings - reaches anyone
with a computer in the college or hospital)
News clipping that I was able to obtain have been included.
AlbanyMedical Center
Department of Public Relations
PRESS CLIP
THE DAILY GAZEITE
+ THURSDAY, SEPTEMBER 8,2005
ALBANY
Albany Med will join
blood subs’titute trial
BY’JILL BRYCE
.
GazetteReporter
Albany Medical Center is one
of 20 traumaceritersin the nation
chosen to participate in national
clinical trials to evaluatethe safety
and efficiency of a red blood cell
substitute that could increasethe
survivalrat& of traumapatients
Although there is no subsfitute
for real blood, this could be used
when there’sa majorbloodlossin
a shooting or motor vehicle accident,for examplq.
We are excitedto be included
in the ground-breakingclinical
frial,” said Dr. Carl Rosatiprincipal investigatordf the study.
Trauma-related injuries are a
leading cause of death among
Americans under 45 years old.
One in five trauma patients dies
from their injuries,saidRosati.
“Tfwecanbegintodeliveran
oxygen-carrying solution very
early and keepthesepatients’hemoglobin levels up, we may see
more survivors,”saidRosatL
The red blood celI substituteis
PolyHeme,a universallycompatible, oxygen-carrying resuscitative fluid derived from human
blood Ambulancesdo n& carry
blood becauseit is such a &agile
substance, so researchers are
searchingfor a product that can
be usedat the sceneof an accident
to savelives,
Under the study, PolyHeme
would be administeredbefore a
patient arrives at the hospital; eitber at the sceneof the injury or in
the ambulance.It then would be
administeredfor 12 hours in the
hospital Nor&field Laboratories
of Evanston,Ill., whi& makesPolyHeme,is fundingtbe study.
The studywill comparethe survival rate of patients receiving
PolyHeme to patients who receive standardcare, which is saline solution, followed in the haspital by donatedbloodif needed.
TO be eli ‘ble for tbe study, patients mustk at least18yearsold,
critically injured, in an emergency’
situation where tbey are losing a
large amount of blood, and in a
stateof shock
Albany Medical Center spokeswoman SueFord said the hospital
is in the ‘public disclosurephase”
and is obligatedto inform the publicabout~eclinicaltrialandwill
alsohost severalmeetings
If the public is not supportive,
the hospitalwill not proceed,said
Ford, but if there’s positive feed~o$~pram
could beginby
.
Patientswith severebrain injuties or irreparableinjuries, those
known to object to blood transfusions due to religious reasonsand
women who are pregnant will be
excludedfrom the study.
Only patientstransportedto Albany Medical Center by the LifeNet “MedFligbt”helicopter or by
ground ambulanceby emergency
medical servicesagencieswitbin
Albany, Schenectadyand Rensselaer counties will be considered
for the study.
Becausepatients who are eligible for the study will probably not
be able to provide consent due to
the extent of their injuries, the
hospital will not seek their permission,asallowedby federal regulatjons for cliqical research in
emergencysettings.
A seriesof public meetingswill
be held and residents can ask
questions,or obtain a braceletthat
allows them tb opt out of the
study. Meetingswill be take place
at 7 pm. Wednesday,Sept 14,and
at 7 pJn. Wednesday,Oct. 5, at the
Huyck Auditorium at Albany
Medical Center.Also, a representative will be at the Empire State
Plazaconcourselevel Sept Is, 20,
2l. 26 and 27.Information is available by calling the PolyHeme responseline at X2-2828.
+
B7
AlbanyMedical Center
Department of Public Relations
PRESS CLIP
m...
..
THURSDAV.sEPTEMBER:~2oos
-.
:.
‘, -w
(
‘.
e-e
Albany Med joins nationwide study of blood
substitute that could help trayma victims survive
,
P
;._
,A,G~,MediM,
cetiier,,,,,,
l
.; YThiiwillbeagreathel tous,”
~saidI&lter@uld,afl’ J taurse
:$&. ma&i, &$&qight, w&&
causemost trauma victims will
not be capableof offering informed consent- a requirement
*
’
I
.rI’here are
BLbD:
Product holds
.
v CON’IINUE~tiOMBl
O.E&al’s recogiiiie, however,
that those meetingswill be of
jqbious: $Iity +po one plans,
aft&.~‘aili-to b&&e 8 trauma
,tiaim. “We’ve been struggling
‘with how to tap into our community,” said Susan Rauch, a
registerednurseand a coordinator of the study.
The study? principal investigator, Dr. C&r1Rosa& saidhe is
ax&dent that PolyHemeis safe.
It hasalreadybeentestedon 171
peopleaspart of the initial clinicaltrials.
.
“The risk profile of this product is less than for blood itself;”
said Rosa& director of the,a=auma section of AlbanyMed’s surry division. The biggest risk
$or blood is that someoneis given
e ;rg
type, an error that can
- not a concern for
PolyHeme.
There are severalsetrings in
which PolyHeme could be inv&able, Rosatisaid:during long
amsports, for a mass casualty
event where blood supplies
mi ht run low and on the battleIi eld. The Pentagonhas been
involvedin the research.
PolyHeme is made from hemoglobm’&xt&5#.ftotn blood.
.LI&~:blopd-&&$&e
saline,
&&I gken wh+i b&&an’t be,
as’
in an ambul&&+‘PolyHeme
is capableof carrj&goi$gen.
Anyone 18 or: fold& who is
tiitically injured andi& suffered
major blood loss.b~%ligiblefor
&e study. During&au ort,
nursesand param+cs wz’ detide whether any
* ’
eligible. The tri r . wiJITeng
domized,meaningon& some of
the selectedpatientswill get Po~YIryyFglJJ~
POLYHEME, a blood substitute,
holds the promise of being a *
Ilfesivf2r for victims of trauma::
of care they would orhenvi&
normally receive.
*
,PolyI-Iemecould alsobe us@
oncethe patient ge-trto the mcrgencydepartment It takesa hospital about 45 minutes to figure
out someone’sblood type. That
time period is critical for someone who has tiered major trauma, Rosatisaid
“We’re looking to limit the
shock phase- that’s our major
killer,” he said
‘MnttPacew&nbereadhea”..
at4544533 or bye-mailat
[email protected].
h.-
Albany Med hospital part of blood substitute study - 2005-09-07 - The Business Review (,.. Page 1 of 2
SBNVlNb
NIW
YORU’S
CAPITAL
REdiON
LATEST NEWS
September7.2005
Albany Med hospital part of blood substitute study
Albanv Medical CenterHospital is one of 16 Level 1 traumacentersin the United Stateschosento participate
in a nationalclinical trial to evaluatethe safety and efficacy of a temporaryoxygen-carryingred blood cell
substituteand its ability to increasesurvival of traumapatients.
PolyHemeis a universally compatible,oxygen-carryingresuscitativefluid derived from humanblood and
designedfor use in casesof major blood loss,when blood is not immediately available.
“We are excitedto be included in this groundbreakingclinical trial,” said Dr. Carl Rosati, the director of the
sectionof trauma,division of generalsurgeryat Albany Medical Centerand principal investigatorof the study.
“Almost one in five trauma patientsdie from their injuries. If we can begin to administeran oxygen-carrying
solutionvery early and keep thesepatients’hemoglobinlevels up, we may seemore survivors.”
Rosati saidthat becauseof !itsfragility, ambulancesare unableto carry blood, so researchersare looking for a
productthat can be used at the sceneof an accident.The study will comparethe survival rate of patients
receivingPolyHemeto that of patientswho receivethe currentstandardof care, which is salinesolution
followed in the hospital by donatedblood, if needed.
Under the studyprotocol, PolyHeme would be administeredbefore arrival at the hospital, either at the sceneof
the injury or in the ambulance,and would continueduring a 12-hourpost-injury period in the hospital.
Becausethe patientseligible for the study are unlikely to be able to provide prospectiveinformed consent,due
to the extentand natureof their injuries, the study will be conductedunder federal regulationsthat allow for
clinical researchin emergencysettings.The Institutional Review Board at Albany Med -- which must approve
the hospital’sparticipationin the study -- requiresthe investigatorsto hold public meetingsto educatethe
public and answertheir questionsabout the study in lieu of informed consent.Membersof the public may
receivebraceletsallowing them to opt out of the study.
. Public meetingswill take place at 7 p.m. Wednesday,Sept. 14 and at 7 p.m. and Wednesday,Oct. 5 at the
Huyck Auditorium at Albany Med. In addition, a representativewill be at the Empire StatePlazaconcourse
level on Sept. 15,20,21,26 and 27. For additionalinformation,call (518) 262-2828.
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NEWSWATCH 50 11WWTI Watertown - 9-7 lo:30 AM News Update - Crown Point Ma... Page 1 of 7
9-7 IO:30 AM News Update - Crown Point
Man Faces Murder Indictment in Toddler’s
Death
CROWN POINT MAN FACES MURDER 1NDlCTMENTIN TODDLER’S DEATH
An Essex County grand jury has indicted GreggaryL. Varmette on three charges,
includingmurder, in the death of a boy he was babysitting.
Varmette,who is from Crown Point, was indicted Tuesday on two counts of
second-degreemurder, first-degree manslaughterand endangeringthe welfare of
a child in conjunctionwith the death of d-year-oldStephen McKay.
Varmettewas arrested on an assault charge Aug. 3 after the child was admitted to
the emergencyroom at Moses-LudingtonHospital in Tiwnderoga. The toddler was
flown to FletcherAllen Health Care in Burlington,where he died early on Aug. 4.
An autopsy done by the Vermont Chief Medical Examiner’sOffice found that
Stephen’sdeath was attributable to head injuries; swelling of the brain; blunt
trauma of the torso and extremities, including contusions and a broken left forearm;
and cardiopulmonaryarrest.
Varmette is being held in the Essex County Jail. An arraignmentdate in Essex
County Court has not been set. (pressrepubtican.wm)
SYRACUSE’S ROBINSON SEES SOME GOOD IN SEASON-OPENING
DEBACLE
It wasn’t exactly the outcome Greg Robinson envisioned for his first game on the
Syracuse sideline.
The first-year coach watched his punchless offense sputter and fizz out in
Sunday’s15-to-7season-openinghome loss to West Virginia, but in the aftermath
of the loss, Robinson says there were some positive signs, includingseveral plays
. . -P.
. ._. I-
------~--:~t~tnrr,Irlpf~l~jt
acnu?nnntent
id=af984c02-66d...
9I12OOO5
NEWSWATCH 50 11WWTI Watertown - 9-7 lo:30 AM News Update - Crown Point Ma... Page 2 of 7
that could have gone for big gains if Syracuse had executed properly.
Junior quarterbackPerry Flattersonhad an erratic game leading the Orange’s new
West Coast offense for the first time.
Overall, he was 15for-32 for 85 yards and two interceptions,one of which was
returnedfor West Virginia’s only touchdown. The Syracuse offense producedjust
103 yards, the lowest total since the Orange managedjust 93 against Iowa in
1978. (Associated Press)
POTSDAMICANTON POLICE STEP-UP ENFORCEMENT
Potsdam and Canton Police Departments have begun their stepped-upfall lawenforcementcampaigns with dozens of arrests in each community. The crackdown
again this fall coincides with back-to-school and back-to-collegeefforts designed to
rein in rowdy behavior. In the past three days, Canton police arrested 34 people of
42 charges and Potsdam police arrested numerousmore. Charges ranged from
vehicle and traffic charges, the most being seat-belt and cell-phoneviolations, to
unnecessarynoise, underagedrinking, marijuanacounts and public urination,
(1340WMSA)
STATE ANALYM A MIXED REVIEW ON CHARTER SCHOOLS
A state analysis has found that charter schools are making academic gains, but
also causing fiscal drains on neighboringtraditional schools.
The reporton the innovative public charter schools will be presentedto the State
Board of Regents Thursday and Friday.
Charter schools operate privately on public funds free from much of the
bureaucracyof traditional Ipublicschools. After six years, they remain the subject of
heateddebate among education officials and the Legislature.
The schools operate on five-year renewable charters that end if the school isn’t
successful.
Among the State Board of Regents findings is that charter schools drain student
aid from traditionalschools to pay for the charter school students’educations.
(AssociatedPress)
NEW YORK EXPECTlNG FIRST HURRICANE EVACUEES THIS WEEK
NEWSWATCH 50 I[ WWTI Watertown - 9-7 lo:30 AM News Update - Crown Point Ma... Page 3 of 7
Several hundredHurricane Katrina evacuees are expected to make their way to
New York as early as this week.
Social service, religious and education leaders are arrangingfor housing, school
and jobs.
State emergencyofficials ha.veasked several counties, including Erie and
Onondaga,to accommodateabout 150 people each.
New York is one of roughly 30 states that have offered to take in those left
homeless by the devastating Gulf Coast hurricane.
Buffalo Common Council Member Antoine Thompson says the city has 200 units
of public housingand 500 units in city-owned property available for evacuees.
Syracuse officials have reserved 120 hotel rooms for the expected influx. The
rooms will providetemporary housing until more permanentarrangementsare
made.
Officials expect the new arrivals to be in their communitiesfor 18 to 24 months,
althoughsome are expecteclto make New York their permanenthome.
(AssociatedPress)
NORTH COUNTRY KIDS RETURN TO SCHOOL
Class was undemay for most parochial school children across the North Country
yesterday, althougha handful of students got a head start last week with freshman
or junior-highorientations. Svmmer construction projects in some districts did not
have any impact on the start of classes. A safety reminderfor motorists: be alert
for stopped school buses and children on the street during morning and afternoon
bus runs to prevent needles:sinjuries or tragedy. Local police agencies will also be
stepping up traffic surveillance with the opening of school. (1340WMSA)
HIGH GAS PRICES COULD COST NEW YORKERS EXTRA $600 MILLION A
MONTH
NEWSWATCH 50 11WWTI Watertown - 9-7 lo:30 AM News Update - Crown Point Ma... Page 4 of 7
SenatorCharles Schumer says that if gas prices don’t start declining, they will cost
New York drivers an extra 600 million dollars a month.
If the high prices continue for a year, Schumer says it will cost the entire state
some 7.2 billion dollars, and New York City drivers would fork over nearly one
billion dollars more than they paid last year.
The figures are based on state gas-consumptionstatistics and triple-A fuel cost
calculators.The statewide average yesterday for a gallon of unleadedwas $3.25.
In New York City, Bdollar gas would mean the average driver pays an extra 45
dollars a month, or 548dolla!rs more per year comparedto the cost last year.
Most industry experts believe the recovery from HurricaneKatrina will bring the
cost of gas back down, but politicians including Schumer are calling for an
investigationof possible prioe gouging.
Lawmakersalso have called for state and federal governmentsto suspend their
taxes on gas. (Associated Press)
SEN. CLINTON CHARGES BUSH HAS WEAKENED DISASTER AGENCY
Senator Hillary Clinton says federal emergency planning under President Bush has
become “a recipe for disaster.”Clinton says FEMA ran far more effectively under
her husband’swatch.
The Democraticsenator is”pushing legislation to take FEMA back out of the
Departmentof Homeland Security. It’s one of a number of signals a political fight is
brewingover what many cornplain has been a bungled governmentresponse to
HurricaneKatrina.
SenatorsSusan Collins and Joe Lieberman said they would hold hearings into the
federal response,but Clinton is pushing for an independentcommission, modeled
on the nine-elevencommission, to investigate governmentlapses and gaps,
The apparentfailings of the federal response led The Times-Picayune,Louisiana’s
largest newspaper,to call for the firing of every federal official involved in the
Katrina response.(Associated Press)
MICHAUD PLEADS NGT GUILTY TO WIFE’S BLUDGEONING DEATH
http://www.newswatch5O.com/common/printstory/default.aspx?~ntent~id=a~84c02-66d...
9/12/2005
NEWSWATCH 50 11WWTI Watertown - 9-7 lo:30 AM News Update - Crown Point Ma... Page 5 of 7
Another not guilty plea from St. Lawrence County murdersuspect Michael
Michaud.
Yesterday he was in county court answering an indictment for second-degree
murderfor July’s bludgeonin,gdeath of his wife Christine in Norwood.Wrth his not
guilty plea recorded,Michaud was returnedto county jail where he’s being held
withoutbail. State Police say Michaud confessed to killing his wife.
MAN CHARGED IN CRASH THAT KlLLED HIS WIFE
A central New York man has been charged with felony vehicular manslaughter
after a weekend crash that left his wife dead.
Authorities say 50-year-oldDanny Reed of Andes was driving a pickup truck that
went off a DelawareCounty roadway early Saturday.
Investigatorssay 52-year-oldKathryn Reed was thrown from the vehicle after it hit
a guard rail. She was pronounceddead at the scene.
State Police say Danny Reed sustained minor injuries. He was treated at a local
hospital and released.
Officials say they expect Reed will face more charges in connectionwith the fatal
crash. The case is expected to be presented to a DelawareCounty grandjury.
(AssociatedPress)
ALBANY MED TO PARTICIPATE
IN STUDY OF BLOOD SUBSTITUTE
Albany Medical Center is among a select group of trauma centers chosen to
participatein a national clinical trial of a blood substitute.
The study will evaluate the safety and effectiveness of PolyHeme, and its ability to
increasethe survival of trauma patients. PolyHeme is a temporaryoxygen-carrying
red blood cell substitute.
httn://www.newswatch50.com/common/printsto~/default.aspx?content-id=a~84cO2-66d...
g/12/2005
NEWSWATCH 50 11WWTI Watertown - 9-7 lo:30 AM News Update - Crown Point Ma... Page 6 of 7
Under the study protocol, PolyHeme would be administered prior to arrival at the
hospital, either at the scene of an accident or in the ambulance. It would continue
to be given during a 12-hour post-injury period at the hospital.
PolyHeme is derived from human blood and is designed for use in cases of major
blood loss, including shootings or car accidents. It can be used when blood is
urgently needed but isn’t immediately available.
Trama-related injuries are a leading cause of death among Americans under 45
years old, affecting more than two million people a year. (Associated Press)
INTERNATIONAL FREEDOM CENTER NAMES FAMILY ADVISORY GROUP
The controversial Freedom Center proposed for the World Trade Center site,
yesterday named a seven-member advisory of September 11th family members.
The International Freedom Center still needs to submit more detailed plans about
its content by September 23,rdto the Lower Manhattan Development Corporation.
Chairman John Whitehead has said that if the detailed plans don’t satisfy the
rebuilding agency it will look for another tenant.
A group of 9-l 1 family members has objected to the Freedom Center, saying it
would detract from the planned memorial and it may host anti-American exhibits.
The family advisory group will advise the center’s board and staff on all aspects of
center programming.(Associated Press)
UNION OFFERS REWARD IN MEMBER’S DEATH
Colleagues of a nursing home aide killed by a stray bullet that pierced her home
are offering 1O-thousanddollars to anyone who can put the shooter behind bars.
Catholic Health System and the upstate chapter of the Service Employees
International Union offered the reward yesterday with the hope of bringing Lottie
Mates’killer to justice.
Matos was cleaning her Buffalo home last month when a masked assailant barged
into the house next door and opened fire on a man in a wheelchair. The bullets
missed the man and his two nephews, but one of the bullets pierced Matos’
window and struck her in the stomach.
Police have said they have no leads or suspects.
htt~://www.newswatch50.com/common/printstory/default.aspx?content-id=af984c02-66d...
g/12/2005
NEWSWATCH 50 11WWTI Watertown - 9-7 lo:30 AM News Update - Crown Point Ma... Page 7 of 7
Matos worked as a nurse’s aide at Nazareth Nursing Home, part of Catholic
Health’s network of hospitals and other facilities. (Associated Press)
US AIRWAYS TO RESTORE SOME UPSTATE SERVICE TO PITTSBURGH
US Airways is planning to restore some service to Pittsburgh from an upstate
airport
The financially-strappedcarrier ended service from the Binghamton Regional
Airport to Pittsburgh last November. That prompted complaints from many frequent
fliers who wound up traveling through the more congested Philadelphia airport.
Broome County executive Barbara Fiala says US Airways has decided to start two
daily flights from Binghamton to Pittsburgh. She says the new service will start
November 9th.
Fiala says she’s pleased US Airways has responded to the request by local
officials to restore direct service to Pittsburgh. The airline will continue to provide
seven daily flights from the Binghamton airport to Philadelphia. (Associated Press)
Albany, N.Y .: Timesunion,.com
Page 1 of 2
print story
back 4
This hospital
test could prove to be a lifesaver
Albany Med joins nationwide study of blood substitute that could help trauma victims survive
By MAm PACENZA, Staff writer
First published: Thursday, September 8, 2005
ALBAN?’-- Patients unlucky enough to be in a serious accident in the next few months may receive a new product with the
potential to revolutionize emergency medicine while a helicopter or ambulance rushes them to the hospital,
The liquid coursing into their veins could be a new substitute for
blood called PolyHeme. Soon to be tested at Albany Medical Center,
it may transform how paramedics and physicians treat trauma
victims - and save lives.
The benefit of PolyHeme, which is made from human blood, is that
it can be stored much longer -- ilt has a shelf life of 12 months,
compared with 42 days for blood -- and can be given to anyone
regardless of blood type, saving critical minutes when each second
matters. Currently, emergency personnel rarely give a trauma victim
blood on the way to the hospital because they don’t know the
person’s blood type.
‘This will be a great help to us,” said Walter Could, a flight nurse
with Albany MedPlight, which transports trauma patients by
helicopter to Albany Med.
Albany Med is one of about 20 hospitals in the study, which is being paid for by Northfield Laboratories of Evanston, Ill.,
PolyHeme’s maker. Researchershope to test the product on 720 patients across the country, a big enough sample to draw
conclusions about its effectiveness and safety.
The study, likely to begin at Albany Med within a month or two, raises ethical questions because most trauma victims will not
be capable of offering informed consent - a requirement for nearly all medical research - before they get PolyHeme.
There are federal regulations that allow for research in emergency settings where consent is difficult to obtain. Albany Med
officials are pledging to do everything they can to get permission from the victim or a family member. They’re also holding
two community meetings to let people know about the research and PolyHeme.
Officials recognize, however, that those meetings will be of dubious utility - no one plans, after all, to become a trauma
victim. ‘We’ve been struggling with how to tap into our community,” said Susan Rauch, a registered nurse and a coordinator
of the study.
The study’s principal investigator, Dr. Carl Rosati, said he is confident that PolyHeme is safe. It has already been tested on 171
people as part of the initial clinical trials.
‘The risk profile of this product is less than for blood itself,” said Rosati, director of the trauma section of Albany Med’s
surgery division. The biggest risk for blood is that someone is given the wrong type, an error that can be fatal - not a concern
for PolyHeme.
There are several settings in which PolyHeme could be invaluable, Rosati said: during long transports, for a mass casualty
event where blood supplies might run low and on the battlefield. The Pentagon has been involved in the research.
9/l 2/2005
Albany, N.Y.: Timesunionxom
Page 2 of 2
PolyHeme is made from hemoglobin extracted from blood. Like blood -- and unlike saline, often given when blood can’t be, as
in an ambulance - PolyHeme is capable of carrying oxygen.
Anyone 18 or older who is critically injured and has suffered major blood loss is eligible for the study. During transport,
nurses and paramedics will decide whether any given patient is eligible. The trial will be randomized, meaning only some of
the selectedpatients will get PolyHeme. The others will get saline or whatever other standard of care they would otherwise
normally receive.
PolyHeme could also be useful once the patient gets to the emergency department. It takes a hospital about 45 minutes to
figure out someone’sblood type, That time period is critical for someone who has suffered majortrauma, Rosati said.
‘We’re looking to limit the shock phase -that’s our major killer,” he said.
All Times Urifon materials copyright 1996-2005, Capital Newspapen Division of The Hearst Corporatfon, Albany, N.Y.
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Albany Med to participate in study of blood substitute
c cBacl(
Albany Pled to participate
in study of blood substitute
ALBANY, N.Y. Albany Medical Center is among a select group of trauma centers chosen to
participate in a national clinical trial of a blood substitute.
The study will evaluate the safety and effectiveness of PolyHeme, and its ability to increase the
survival of trauma patients. PolyHeme Is a temporary oxygen-carrying red blood cell substitute.
Under the study protocol, PolyHeme would be administered prior to arrival at the hospital -either at the scene of an accident or in the ambulance. It would continue to be given during a 12hour post-injury period at: the hospital.
PolyHeme is derived from human blood and is designed for use in cases of major blood loss,
including shootings or car accidents. It can be used when blood Is urgently needed but Isn’t
_ immediately available.
Trama-related injuries are a leading cause of death among Americans under 45 years old,
affecting more than two (m) million people a year.
Copyright 2005 Associated Press. All rights reserved, This mateerial may not be published,
broadcast, rewritten, or redistributed.
/
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I
All content 0 ICopyright2000 - 2005 WorldNowand WSTM, a Ravcom Media Station.
All Rights Reserved.For nnoreInformation on this site, pleaseread our Prlvacv Pollg and msof
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Service.
j
9/7/2005
ALBANY TIMES UNION
News Plaza
Box 15000
Albany, New York 12212
STATE OF. NEW YORK
COUNTY OF ALBANY
T. Dollard
/ i,,
is Principal
\
of Colonie,
an wkl
-am
4
aforesaid
and t
the said ALBANY'!
'ii$
au;
09-08-2005
v WI,
09-11-2005
\@ffi
t**
09-13-2005
\
Sworn to before
me, this
of the City of Albany, being duly sworn, says th
SS UNION, a daily newspaper printed
in the County of
County of Albany, Town of Colonie and the City of
ch a printed
copy is annexed has been regularly
pu
.'$the
followina
dates:
:L3th day of September
2005
w
Acct.
Albany
Coap&
#070075003
Jodi M. (Kelly)Burick
Notary Public, State of Ner
“-$q$
,i: , 3);
Qualified in Albany COL
Q!!s
CommissionExpiresOct. 15
3“Wp
No. 4898040
ss.:
State of New York,
City and County of Schenectady
2-E%&
Albany Medical Center of
Albany, New. York is one
of a select number of
Level-i trauma centers in
the United States co’nsld$~QJp$atJO~
jtlitl
otentially
IIfe-saving
Preatment
for. severelv
injured patients who are
bleedlhg, and in shock.
The stud
Is being conYor approval by
Mered
the Western lnstltutional
Review Board WIRB) of’
Alban . Medlca \ Center
Thh &dy
uses a prow:
sion’ for an ‘exception
I
from Informed
consent
requliements
in actordance wlth federal I
able to rbi;ide~Lonsent
due to Phe nature and
extent of their In wles.
Patlen& their lega i lyauthortied!
representati
or a famll
member wll
“r
be notifier?at the earllest
0 Portunl
and their inc Puslon an B the debslls of
theresearchshrdy.
__
A communitv
meetina
Amv Hills of the City of Schenectady,being duly
sworn, saysthat he/sheis Principal Clerk in the office of
the Daily Gazette Co., published in the City of
Schenectady and that the notice/advertisement, of
which the annexed is a printed copy, has been
regularly published in the Daily Gazette and/or Sunday
Gazette as follows:
3 insertionsSept.8,11,132005
&Y-q
7aLY.J
Sworn to me on’this 14’”day of September2005
NOTARY PUBLIC
LISA J. BALDWIN
COMMTSSION~ OF UEEDS
My commission expire: L,a8*
b-9
WAM”N
10 ales ‘3llwld
3l.OOA Vl3YUVd
AWlON
f
A2IV.LON
I
..
____.___
l_. ,.. _.. ._- ..- _-_.___
.
:-
., :
.
ALBANY TIMES UNION
News Plaza
Box 15000
Albany,
&I$$
$$$g
\
the said AL
New York 12212.
STATE OF NEW YORK
COUNTY OF ALBANY
"YY'@'?nedict
of the City of Albany, being duly sworn, says that he/she
cm ,:$;
B.:$?'IMESUNION, a daily newspaper printed
in the County of Albany, Town
,:l~l the County of Albany, Town of Colonie and the City of Albany,
which a printed copy is annexed has been regularly
published
in
dates:
c
3n
the
following
\
09-25-2005
09-29-2005
10-02-2005
10-04-2005
Sworn to before
me, this
4th day of October
2005
U
Acct.
#070075003
Jodi M. (Kelly)hick
Notary Public, State of New Yzk
Qualified in Albany County
CommissionExpiresOct. 19, 2005
No. 4898040
State of New York,
City and County of Schenectady
ss.:
Amy Hills of the City of Schenectady,being duly
sworn, saysthat he/sheis Principal Clerk in the office of
the Daily Gazette Co., published in the City of
Schenectady and that the notice/advertisement, of
which the annexed is a printed copy, has been
regularly published in the Daily Gazette and/or Sunday
Gazette as follows:
4 insertionsSept.25,29 Oct. 2,4 2005
blti
#/u
Sworn to me on t&s 5* day of October2005
NOTARY PUBLIC
NO XIBdVdSMElN CIIVS NI CIBHSI18fld SVM E)NISI.LXEIACIV
W9B-I f)NIO%lIOd
iU3.l .I.VH.L %IdVdSMBN WDIddO 3H.L ‘NVIE)O.JXVXVS 3H.L 60 X?ITI3
WdI3NRId BELL SI BHS .LVH.L :SAVS CINV SBSOdEKI ‘NXOMS AvlC? tXEt8 aBI3?I VI3RLJaVd
--
From:
To:
Date:
Subject:
Sue Ford
Rauch, Susan
9/13/05 3:40:06 PM
Other lOutlets
Hi Susan,
-
-4
The Times Union and Qoitai News 9 said theyii post the forum for us tomorrow, I also made calls to the
Saratogian and SpotlighJnewspapers to see if there is anything additional they can do for us.
Rick Cook says that the SUNY Albany School of Public Health has presentations almost daily and that this
would be a good forum for you. You might want to give them a call.
Also, I did learn that the RPI research is part of our ethics department’s research. No need to call Liva if
you haven’t already.
Sue
From:
To:
Date:
Subject:
Sue Ford
Rauch, Susan
9/15/05 1:04:30 PM
PolyHeme
Hi Susan,
Here’s the list of media outlets that I know have definitely covered PolyHeme:
Business Review, Troy Record, Times Union, Daily Gazette, WRGB, WNYT, WXXA, WTEN, Capital
News 9, WGY, WAMC, and the Saratogian has said that they will at some point this week.
The Times Union also mentioned the community forum in their calendar listing.
If you do a Google search, you will see many more.
I plan to reach out to the YMCA VP this afternoon.
Sue
Sue Ford
PR Specialist
Albany Medical Center
43 New Scotland Avenue
Albany, NY 12203
518-282-3421
518-282-3880 (fax)
[email protected]
From:
To:
Date:
Subject:
Nicole Harte
Rauch, Susan
Fri, Sep 16.2005 856 AM
Fwd: Public Notices
Heard you were looking for the run dates.
Nicole
>>> Nicole Harte 8/26/2005 9:31:48 AM >a>
Susan,
Here’s my public notice plan for the two public forums being planned in Huyck.
Run dates for the 9114forum:
TU, Gazette, Troy Record, Post Star, Saratogian- 9/8,9/l 1, 9113
Spotlights - 9/14
Jewish World - 918
Run Dates for the lo/5 public forum:
TU, Gazette, Troy Record, Post Star, Saratogian - g/25,9/29, 1O/2, 1014
Spotlights - 9128, 1015
Jewish World - 9115, 9/22,9/29
Let me know if you have any questions.
Nicole
cc:
Ford, Sue
‘ ....,. ” ,I~ ,. .,,, \,, _ . I /. . . .,*,._ ,_,..--., / . ,,e . I
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,-. .1 .i_ _ _ ,).”
I_-.....,,* . > _8 I,, P-/ a g .e..e,1/J
Susan Rauch
j e r r y g o r d a n @ j u n o .co m
P o lyh’e m e S tu d y In fo r m a tio n
Dear Mr. Gordan,
A l b a n y M e d ical C e n te r is o n e o f several
L e v e l I t r a u m a c e n ters in th e U S c o n s i d e r i n g p a r ticipation in a clinical stu d y to e v a l u a te th e life sustaining
p o te n tial o f a n investigational p r o d u c t in th e treatment o f severely i n j u r e d p a tie n ts w h o a r e b l e e d i n g a n d in
shock.
U n d e r fe d e r a l r e g u l a tio n s , a prerequisite fo r s u c h a n e m e r g e n c y m e d icine stu d y is a p e r i o d o f public
disclosure/community consultation d u e to th e p r o b a b l e inability to o b ta i n prestudy c o n s e n t.
Carl R o s a ti, M D , Director o f T r a u m a , D e p t. o f S u r g e r y is th e principal investigator a t A l b a n y M e d ical
C e n te r . T h u s fa r , w e h a v e u s e d c o m m u n i ty m e e tin g s , T V , R a d i o a n d n e w s p a p e r n o tice s in o r d e r to
inform th e t&city a r e a .
W e also w a n t to o ffe r th e o p p o r tunity to c o m m u n i ty o r g a n i z a tio n to h a v e a p r e s e n ta tio n , a c h a n c e to
ask q u e s tio n s a n d voice th e i r opinions.
O u r information/opinion line a n d w e b site a r e listed
In fo r m a tio n L i n e : 2 6 2 - 2 8 2 8
W e b P a g e : w w w .a c m c . e d u l o o l v h e m e
below.
P l e a s e let m e k n o w if a n y local L i o n s C l u b o r g a n i z a tio n s w o u l d b e interested. T h a n k y o u a g a i n fo r y o u r
help1
Susan Rauch
S tu d y C o o r d i n a to r
r a u c h s @ m a il.a m c .e d u
262-6608
From:
To:
Date:
Subject:
Jerry Gordon [email protected]>
<Rauc:[email protected]>
9/l 9/05 1 :I 6:50 PM
Re: Polyheme Study
Susan,
Below is a list of whom I forwarded your email to. I selected the clubs
in the immediate Capital District, and wrote to the president, if s/he
has email. (But for the Troy club, I sent it right to our Program Chair.)
Albany Lion Club: Larry Krug, Acting Pres, 436b3273, [email protected]
Ballston Spa Lions Club: Christopher Jackson, Pres, 564-1337,
whiteskates44@hotmalLcom
Bethlehem Lions Club: Jeff Buenau, Secretary, 283-3736,
buenausopticians@aolxom
Guilderland Lions Club: Jean Mann, Pres, 452-1237,
[email protected]
Rotterdam Lions Club: Paul Andrews (only one I’ve got email for),
[email protected]
Saratoga Springs Lions Club: Peter Brown, Pres, 583-9439,
[email protected]~om
ScotialGlenville Lions Club: Nancy Larson, Pres, 8850968,
[email protected]
Shenedehowa Lions Club: , Bob Chatelain, Pres, 371-2664,
[email protected]
Troy Lions Club: Joann Beach, Program Chair, 489-7606,
[email protected]
Water-ford Lions Club: Carl Mossner. Pres, 664-6726,
[email protected]
I hope you get some speaking engagements.
Best regards,
Jew
Clinical Investigator
PolyHeme@
Trauma Trial
Carl Rosati MD, FRCSC, FACS
l
Community Consultation
Co-Investigators Albany Medical Center
Emergency Dept. and Trauma Surgery
Service
l
ALBANY MEDICAL (zm-rER
www.ame.eduloolvheme
5 18-262-2828
Study Sponsor
Study Purpose
Northfield Laboratories Inc.
Developa
of the oxygen-carrying resuscitative
fluid called PolyHen@
Conductedmultiple studieswith PolyHeme
over the past decade
Most studieshave beer with injured trauma
patients
9 Company website:www.norlirflelldlobcom
To evaluate the life-sustaining potential
of PolyHemP
when given to severely injured
and bleeding patients in
“hemorrhagic shock,” starting at the
scene of injyv
What is Hemorrhagic Shock?
Need for Improved Outcome
l
l
l
Hemorrhagic
massive loss of blood
SlrocR: lifethreatening
condition
Dangerously low blood pressure
l
l
l
Internal organs don’t receive enough oxygen
and have difficulty ftmcticning
Might lead to death
The Center for Disease Control (CDC) lists
trauma as the leading cause of death among
Americans under age 45
l
l
l
Thousands of trauma patients die each year
Many of these patients die because the
“standard of care” cannot reverse the
damaging effects of hemorrhagic shock
1
I
What is the Standard of Care?
Standard of Care Limitations
In the Ambulance
Representsthe current treatment
l
In rhc Ambuiance
In lhe Harp&at
The patientreceives
saltwata
(blood is not available)
The patient receives
salt watt
and donatedblood
I
Salt water does not carry oxygen, unlike
blood
Without enough oxygen, the body and its
internal organs have difficulty functioning
and can stop working (organ failure)
l
I
I
l---------l
I
What is PolyHeme@?
Standard of Care Limitations
In the Hospilol
Risksassociatedwitb lar c infusions of donated
blood in traumapatientst ave been identihd
- Inereascin immune fuacrtion,which may oause
f&ilure of vital organs and death,observedin some
patientswho have receivedtransfusions*
l
‘A. Szwia cl al., Alchives 0fSwgcry
V&me 129:39-U
A temporary red
blood cell
substitute
that carries oxygen
In the acute setting, 1
unit @int) of
PolyHeme is given in
place of I unit @ini)
of blood
(1994),
What is PollyHeme@?
l
l
l
l
Made from human
blood
Compatiblewith all
blood types
Immediatelyavailable
Mauufaoturedwith
stepsto reducethe risk
of viral transmission
Why Use PolyHeme@?
* PolyHemewas developedto treat urgent, large
volume blood loss
Bloodis notnomwIIyavailablein fheambulance
- PolyHcmcwill be immcdia~ely
availablein the
ambulance
andcarriesoxygen
l
l
PolyHememay reduce the use of donatedblood in
the fmt I2 hours after injury, and might avoid
potential organ failure
2
Why Use PolyHeme@?
Why Use PolyHeme@?
There are risks associated with large infusions of
donated blood in trauma paticntsr
l
In a controlled Phase II trial in hospitahxed trauma
patients, higher levels of immune markers were
seen in patients who received blood transfusions
as compared to those who received PolyHemc2
l
To evaluate a potential improvement in
survival of severely injured and
bleeding patients
‘A. Saw/a et al., Anahivcl of Surgery (1994), Voltme
129.394
IE. E. Moon, Jourml ojlmericon
Surgeons (2003). Vohmr! 196 (I)
I
CoIrCge of
I
PolyHeme@ Experience: Past
Administered to patients with acute blood loss in
the hospital setting
l
l
PolyHeme@ Experience: Past
l
Patients have received u 1to 20 units (pints) or
I.000 gm of PolyHem ed
Normal volume of blood in a human is 10 units
(pints) or 500 gm of hemoglobin
l
[Gould et al, Journal of American
College of Surgeons (2002), Volume 195
Some of these patients ke t alive while losing
l
virtu$y all of th@r,own Blood during ongomg
f&yIeant
recetvmg only PolyHeme@ as
I
I
I
Observations in these patients have
suggested the life-sustaining potential of
PolyHeme @ in the treatment of urgent lifethreatening blood loss and life-threatening
hemoglobin levels
(4)/
I
PolyHeme@ Experience: Past
l
During the course OF evaluation of any
investigational product, both adverse
experiences and serious adverse experiences
can occur. These may be due to either:
the underlying condition ofthe patient
1
I
PolyHeme@ Experience: Past
l
l
thetmtmentscttingor
l
the investigational product itself
Both adverse experiences and serious adverse
experiences have occurred in prior studies.
I
l
l
l
One trial conducted in older patiatts undergoing
elective surgery for abdominal aortic aneurysm that
involved a non-routine procedure whae up to 6&?/o
of their own blood was removed and later replaced.
Serious adverse evmts, including cardiovascular,
were observed.
It cannot be determined whether due to
experimental procedure or PolyHeme itself
l
l
Patients in this study were older with more
cardiovascular risk factors than those in the trials in
3
I
PolyHeme@ Experience: Past
I
720 patients will be enrolled:
360 patients in the control group
360 patients in the PolyHeme@group
Currently, enrollment underway at a 17 Level 1
trauma centersacrossthe United States
A list of centersis available at
www.clinicaltrials,aov
The FDA has approved the study
22 lnstitotional Review Boards have proved tbe
study. 1 IRB has not approved the st3 y
l
In traumn atients, PolyHemeQ has been
rapidly in R sod during urgent life
threatening blood loss in sufficienti large
quantities, up to 20 units (mints), to L
considered well-tolerated in this patient
population.
l
PolyHeme@ Experience:
Current Trial
l
l
l
l
[Gould et al, Journal of
American Coliege o Surgeons
(2002), vohle
19 f (4)]
l
l
t
1
PolyHeme@ Experience:
Current Trial
PolyHeme@ Experience:
Current Trial
l
l
l
An IndependentData Monitoring Committee set
up to review mortality and serious adverse
expuimces after 60,120,250 and 500 patients
have been enrolled and followed for 30 days
Committeehas revieweo the safetydata on the
fvs 60,120 and 250 patients
Committeehas tecommendedthat the study
continuewithout any change
Trial Design: Before the Hospital
l
l
l
At the 250 patient look, Committee conductedan
adaptive sample size determination.
Assessmentwas based on a comparison behveen
the mortality rate predicted in the protocol and the
observed mortality rate in the trial to date.
Committeehas concluded that no adjustmentin
the number of patientsto be enrolled in the study
is required.
Ambulance Infusion
Severely injured trauma patients will be
assigned to either one of two groups
by chance
Control
Receivesaltwater
(360 patients)
Test
ReceivePolyHemeQ
(360 patients)
4
Hospital Inkion
Trial Design: At the Hospital
Test
c0Ilfr01
Salt water for
l
l
hydration
. Donated blood to
boost oxygen levels
l
l
l
Salt water for
hydration
PolyHcmeQ to
boost oxygen levels
Maximum dose of 6
units during fti 12
hours
Donated blood will be
used thereafter
Who Would Be Excluded?
Who Would Be Included?
Patients at risk of dying
Patientswho are
obviously pregnant
l
9 Who have sustained severe injuries
l
l
l
who are at least 18 years old
l
FDA Review
l
l
Patients who have
“tmsurvivable”
injuries
Who are of either gender (male or female)
l
l
severehead or brain
injuries
Who have lost a large amount of blood and
are in shock
l
Patients who have
’ Patip*require
l
Patients with known
objectionsto blood
barmizions
Patients with known
orders not to resuscitate
Patientwith visible or
identifiable method of
objection e.g.wearing
exclusionb mcelet)
I
I
What is Informed Consent?
I
A process by which patients make informed
decisions about participating in research
studies
Northfield Laboratories received clearance
to proceed with this study from the Food
and Drug Administration (FDA)
The FDA authorized the use of an exception
from informed consent requirements for this
study
Traditionally required for all research studies
l
l
l
I
Rosearchstudiescompare 2 troarments
(standardvs. investigational)
Doctors describe each of thosepotmtial
treatments
I
I
What is Informed Consent?
I
What is Exception from Informed
Consent?
A process by which patients make informed
decisions about participating in research
Patients are enrolled in a
research study without giving
their informed consent
studies
Patientsare informed of the potential risks and
l
potential benefits associated with each of these
treatments
Patients choose whether to participate in the
study
l
How Can That Be?
How Can That Be?
A federal regulation (21 CFR 50.24), created
in 1996, allows certain studies that meet the
following criteria to use this exception
A federal regulation (21 CFR 50.24), created
in 1996, allows certain studies that meet the
following criteria to use this exception
l
l
Patients’ lives must be at risk
l
Available treabncnts are not satisfactory
l
Patients are unable to give consent
l
Potential risks are reasonable
Participation in the research could provide a
direct benefit (increased survival) to tbc patient
l
l
The research could not be practicably carried
out without an exemption
Consent Safeguards
Consent Safeguards
If possible, the patient or a legally
authorized representative (LAR) can give
consent before the patient is enrolled in the
study
*If consent cannot be obtained before
enrollment, frequent attempts will be made to
contact the patient’s LAR and family to
describe the study
*The patient., family members, or a legally
authorized representative may decide to
withdraw the patient at any time
6
Potential Benefits of PolyHeme@
l
l
Potential Risks of PolyHeme@
I
Can enhance the amount of vital oxygen in the
patient’s blood (prehospital setting)
May avoid failure of vitsll organs (prehospital and
hospital settings)
l
Rash
l
Tncreased blood pressure
l
Kidney or liver damage
l
Might increase the IikeliJ~ood of survival
Is compatible with all blood typos
l
Viral infection (HIV, hepatitis, etc.)
l
l
Is immediately available
l
Unforeseen happenings
l
Manufactured with steps to reduce the risk of viral
transmission
Patient Protection
The Institutional Review Board (IRB) is a
group of medical, scientific, and nonscientific
members of the community
l
Reviews all proposals for research on humans
l
Assures patient safely
l
Monitors community feedback
l
l
l
The IRB will decide whether or not to allow
this hospital to participate in the
PolyHeme” trial
An Independent Data Monitorin
Committee is overseeing the tn*f to monitor
the safety of the product
The FDA is being informed of the trial’s
progress
I
I
If We Participate.. .
l
The results of the study will be revealed to
the community after the trial has been
completed
l
‘Ihose who do not wont to participate in the
study can wear a special bracelet to exclude
themselves
Questions
or
Comments?
7
Community Meetings Summary
Date
Entered
I
Ethnic Group
3endel
Jrvey Respor
I Meeting
Qw Attended
ciaratoga
VI 2105
BS
Survey
Iuestiot
- 1
Survey
h3StiOl
2
INo Attendance
:ommunity
I
nlleeting
EImpire
itate Plaza
.;
i ESP)
Ic
aucasian
E.SP
'33
es
E.SP
es
es
EISP
f E.SP
es
'es
es
es
E.SP
'es
es
I ISP
i ISP
EiSP
- '8S
'es
'8S
es
es
es
es
8S
es
.SP
es
BS
8S
Cl
-TEL
n
A
one ive
I
n
Caucasian
i
1
*
Irish American
None given
Irish American
,Caucaslan
--
SP
SP
SP
SP
SP/web
none
I feel, if a
person’s
chance of
survival is
increased, ie)if
person get
polyheme
person will live
or if doesn’t gel
it person will
Community Meetings Summary
I
sian
:O
:4
ESP
ESP
es
es
es
BS
W
W
BS
ii"-es
es
es
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Community Meetings Summary
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Community Meetings Summary
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Community Meetings Summary
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Community Meetings Surmnq
September 12,20015
Saratoga Library Community Meeting
Activity:
Study presentation by Carl Rosati, MD
Arrangement made on September 7’ and placed on library events calendar.
NO ATTENDENCE
The study coordinatir spent.part of the afternoon distributing brochures to the town hall,
library, and Starbucks (reading table). I also when to the student union of Skidmore
College to post copies of the brochure on bulletin boards and left about 25 copies.
09/07/2005
SARATOGA
510-504-7066
10:49
Saratoga.
49
Henry
Springs
St. Saratoga
Public
Sptigs,
PAGE
LIBRARY
Library
Meeting
03/04
Room
Request
NY 154866 584-7860
Please be advised of %e following:
l
l
Meeting room UJ& may not enter the buildingprior
minutes a&r thelibraty closes.
to opening, and meefings must end 45
Attendees shoula! a&o be advised that there is a strictly enforced Z-hour parking limit in the library
parking lot
l
Hease contact us ifyou n&ed to cancel your meeting.
l
Setup of chairs nnd tables is the responsibility of the meeting room users, not librta y stafl
Bad Weather: Please call the library for any atmouncements of closing due to inclement weather.
252SQd
ContactPerson forThiskleei$ng:
Contact Person Phone Number:
Address, City, State, and 22”:
Z+Z+L&
5;s T .QJ& - && y
A#+
pd. d//d, Oii -91 . c! 7&W&&h
4
#Of.
: /4/b
M, /c'y
J
(The name & number of the contactperson will be made available to anyone inquiring abou; a meetind
Email Address (Zfany): ,I?
&Lk^ 5 @ m at ‘/ I A, 1IC * Id&
Please check one of the three rooms below, Note: The occupancy limits reflect the fire code and may not
be exceeded. If you expe’ct more people, please plan for a larger room.
n/ Community Room
120 people maximum
q
]Susman Room
30 people maximum
q Glasby Room
20 people maxfmum
Comes Wb!h:
Comes WiLh:
30 chairs
3 tables
.
sink
M-cup coffee maker
white board/markers
tack board
data projector & screen
Comes H&h.20 chairs
2 tables
sink
15-cup coffee maker
white boa&markers
tack board
data projector & screen
120 chairs-setup & breakdown by group
15 tables-setup & breakdown by group
kitches & large coffee maker
platform stage (24’ by 14’)
lectern
public addresss system
data projector & screen .
piano (on the stage)
vacuum for cleanup
Additional equipment may be ovalable. Please contact Sue Pettit at (518) 584-7860 exL 264, f&x- SW-7866
or email address: [email protected]. Please contact us 72 hours in advance of your meeting to discuss any
equipment needs or connection requirements you may have. Also be aware that we may not always be able 10
repair equipment dwing your meeting.
The library provides Heariug assistance equlpment for use in meeting rooms. PIease he@ m&e this
equipment available as needed.
Confirmed by:
Date Co&-me&
1
/ Jac%
09/07/2005
SARATOGA
518-5134-7866
10: 49
LIBRARY
PAGE
02/04
SARATOGA
SPRINGS PUBLIC LIBRARY
49 Henry Street, Saratoga Springs, NY 12866-3271
. (518) 584-7860
FAX (518) S W -7866
www.sewl.org
l
Meeting RoomsPolicy
Article six of the American Library A.wociation Bill of Rights, which has’been endorsed by the Saratoga
Springs public Library, reads as follows:
l
I&raries which make exki%itspaceand meeting rooms available to the public they serve should
make such fstcilitits available on an equitable basis,regardless of rhe beliefs or afGliations of
individuals or groups requesting their use.
The Saratoga Springs Public Librsry maintains three meeting rooms which may be used by commuuity
&roups and agenciesI[not individuals) when not being used for library purposes, subject to the following
guidelines approved by the library boar&
to the citizens
1. Rooms are available to groupe witi headquartersin or that provide substantial sex-vices
of the Saratoga Springs Enlarged City School District
2. Meeting moms may not be used for commercialand/or for pro& purposes. This includes such
programs as mvosstmcnts-s,
sales/servicedemonstrations,demonstrations by private for-profit
limlth care practitioners, etc.
3.. All meetings and programs shall be free and open to thepublic, and room mcy not be usedfbrjmdraixerx such as garage sak,
4
The h*
bake sales, etc.
resuvas the right to cancel a reservationfor library purposes.
5. All groups aceresponsible for damage and are rquircd to leave icacilties in a clean and drderiy
condition
6” When scheduled for we by minors, an adult supervisormust be present at all times.
*. . :
7. No alcoholic beverages may be consumedon library property.
8. No smotig is allowed in the Library building.
9. The likary encourages use of meeting rooms fti diverse eventsand groups and seeksto give all
eligible organizations sn opportunity to use our services.For these reasons,no group may nswe a
mom more than 12 months in advance.AU groups are encouragedto End other facilities for regularly
scheduledmeetirlgs when possible. Meetiag rooms may not be scheduledmore than 12 times in a
.
13month period.
10. Bookings must be made at least48 hours in advance,and for groups of no fewer than five people.
Meetings must begin during library hours and be completedno later than 45 minutes after closin,o
hour. No meetings may be scheduledon a day the library is closed. If arrangements are made in
advance,meetings may extend beyond the 45=xninutelimit for a fee of 525.00 per hour.
.
11,
Neither the name nor addressof the SSPL may be used as the official address or headquarters of an
organization. Pubticiry for eventsin the library should clearly idea@ the sponsoring organization.
Telephone queries should be made to the sponsoringorganization
Amended December &ZOO3 by the SSPL Lihrery Board
.
E
!E
09/07/2005
10: 49
SARATOGA
518-584-7866
LIBRARY
PAGE
01/04
Fax Cover Sheet
FROM:
SUE PETTIT
PHONE:
FAX:
5&w-7860
EKt.
264
W-584-7866
RE:
. cc: *
Nmber of pages incl udhg
Message
.
cover sheet: 4
Here is tb papwmdc that I spoke to you about on the ph&e. &ut keep the Mtg. Rm
Pkase s5I.Iout md fix back to me the Mtg. Rm. Request
and User Registmion f6m.s. I will then sign and ti back your confiimat~~. I~YOU.
have any other guehx~~ or YOUneed to cancel your request,please give me a CEQ al: the
above number. Thank you.
*
PdiCY for your own rdhnct.
.
Community Consultation
Albany Medical Center Community Meeting
g/14/2005
Please circle your answers
1. Would you support a study such as the one described at this meeting being conducfed
in this community, specifically, a study in which severely injured and bleeding patients
would be enrolled without giving their informed consent?
No
:
2. If you were severely injured and bleeding and were being treated by the paramedics in
your community, would you want to be enrolled in thistype of study?
No
3. If a family member of yours were severely injured and bleeding and were to be treated
by the paramedics, would you want him or her to be enrolled in this type of study?
0
No
Yes
4. Do you have any comments or concerns you wish to share with the investigators?
Ethnic background: mu
Age: G-4+
Gender:
Male
Female -lc;
e’m
’
Thank you for your participation today.
Please call Susan Rauch at 5 18-262-2828 if you have any other questions.
Community Consultation
Albany Medical Center Community Meeting
9/l 412005
Please circle your answers
1. Would you support a study such as the one described at this meeting being conducted
in this community, specifically, a study in which severely injured and bleeding patients
would be enrolled without giving their informed consent?
No
2. If you were severely injured and bleeding and were being treated by the paramedics in
your community, would you want to be enrolled in this type of study?
,?
(y4Y
No
L-l
3. If a family member of yours were severely injured and bleeding and were to be treated
by the paraniedics, would you want him or her to be enrolled in this type of study?
-‘-- -\
No
Yes ’
.) .-_..
4. ‘Do you have any comments or concerns you wish to share with the investigators?
Ethnic &&gtou&
Age: %b
Gender:
Male
L’
r cmcbid dch
Female
Thank you for your participation today.
Please call Susan Rauch at 5 18-262-2828 if you have any other questions.
Community Consultation
Albany Medical Center Community Meeting
9/14/2005
Please circle your answers
1. Would you support a study such as the one described at this meeting being conducted
in this community, specifically, a study in which severely injured and bleeding patients
would be enrolled without giving their informed consent?
’ No
clYes
‘L.
2. If you were severely injured and bleeding and were being treated by the paramedics in
your community, would you want to be enrclled in this type of study?
No
3. If a family member of yours were severely injured and bleeding and were to be treated
by the paramedics, would you want him or her to be enrolled in this type of study?
No
<es&/
0
4. Do you have any comments or concerns you wish to share with the investigators?
Ethnic background:
Age: <; ~1
Gender:
Male --
ijj
Female /
Thank you for your participation today.
Please call Susan Rauch at 518-262-2828 if you have any other questions.
Commuuity Consultation
Albany Medical Center Community Meeting
9/l 412005
Please circle your cmswers
1. Would you support a study such as the one described at this meeting being conducted
in this commtity, Sspecifically,a study in which severely injured and bleeding patients
would be enrolled without giving their informed consent?
2. If you were severely injured and bleeding and were being treated by the paramedics in
your community, would you want to be enrolled in this type of study?
No
3. If a family member of yours were severely injured and bleeding and were to be treated
by the parat&dics, *would you want him or her to be enrolled in this type of study?
No
4. Do you have any comments or concerns you wish to share with the investigators?
Thank you for your participation today.
Please call Susan Rauch at 5 18-262-2828 if you have any other questions.
Community Consultation
Albany Medical Center Community Meeting
g/14/2005
Please circle your answers
1. Would you support a study such as the one described at this meeting being conducted
in this community, specifically, a study in which severely injured and bleeding patients
would be enrolled without giving their informed consent?
2. If you were severely injured and bleeding and were being treated by the paramedics in
your community, would you want to be enrolled in this type of study?
No
3. If a family member of yours were severely injured and bleeding and were to be treated
by the paratnedics, would you want him or her to be enrolled in this type of study?
No
4. Do you have any comments or concerns you wish to share with the investigators?
Age: 0
Gender:
Ethnic background: ,&L?&
Male
Female
‘/
,$.!$&!A
,
I/
Thank you for your participation today.
Please call Susan Rauch at 518-262-2828 if you have any other questions.
Community Consultation
Albany Medical Center Community Meeting
9/14/2005
Please circle your answers
1. Would you support a study such as the one described at this meeting being conducted
in this community, specifically, a study in which severely injured and bleeding patients
would be enrolled without giving their informed consent?
,,,: /
Yey”
No
,J’
2. If you were severely injured and bleeding and were being treated by the paramedics in
your community, would you want to be enrolled in this type of study?
No
.P t ;es 1;
c/
3. If a family member of yours were severely injured and bleeding and were to be treated
by ,e paran&iics, would you want him or her to be enrolled in this type of study?
/”
No
/yesi
‘0’
4. Do you have any comments or concerns you wish to share with the investigators?
! ‘!
Age: @
Gender:
Male
Thank you for your participation today.
Please call Susan Rauch at 518-262-2828 if you have any other questions.
Albany Medical Center Community Meeting
g/14/2005
Please circle your answers
1. Would you support a study such as the one described at this meeting being conducted
in this community, specifically, a study in which severely injured and bleeding patients
would be enrolled
were being treated by the paramedics in
your community, would you want to be enrolled in this type of study?
YeS
No
3. If a family member of yours were severely injured and bleeding and were to be treated
by the partiedics, would you want him or her to be enrolled in this type of study?
Yes
No
0.A
4. Do you have any comments or concerns you wish to share with the investigators?
Age: (
7%
Gender: Male -_
Ethnic background:
Flak---
.
w LL
J
Thank you for your participation to&y.
Please call Susan Rauch at 518-262-2828 if you have any other questions.
Community Consultation
Albany Medical Center Community Meeting
g/14/2005
Please circle your lanswers
1. Would you support a study such as the one described at this meeting being conducted
in this community, specifically, a study it! which severely injured and bleeding patients
would be enrolled without giving their informed consent?
5z’No
f
i-. ./”
2. If you were severely injured and bleeding and were being treated by the paramedics in
your community, would you want to be enrolled in this type of study?
c---.3
No
3. If a family member of yours were severely injured and bleeding and were to be treated
by the pdedics,
would you want him or her to be enrolled in this type of study?
No
a
4. Do you have any comments or concerns you wish to share with the investigators?
Ethnic background
Age: x&’
Gender:
Male --
Female 1’
Thank you for your participation today.
Please call Susan Rauch at 5 18-262-2828 if you have any other questions.
Community Consultation
Albany Medical Center Community Meeting
9/14/2005
Please circle your mswers
1. Would you support a study such as the one described at this meeting being conducted
in this community, specifically, a study in which severely injured and bleeding patients
would be enrolled without giving their informed consent? .
g*:
No
_...
2. If you were severely injured and bleeding and were being treated by the paramedics in
your community, would you want to be enrolled in this type of study?
3. If a family member of yours were severely injured and bleeding and were to be treated
by the paran%dics, would you want him or her to be enrolled in this type of study?
No
4. Do you have an comments or concerns you wish to share with the investigators?
2.k.C 2 i (-G J-- ,-“&9 j.& &. .A&*,
I
Age: >q
Gender:
a
Male
5\1
Ethnic background:
J
L
Female
Thank you for your participation today.
Please call Susan Rauch at 518-262-2828 if you have any other questions.
Community Consultation
Empire StatePlaza
9/l Y2005 to 1O/03/2005
Please circle your answers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolledwithout giving their informed consent?
0
Yes
No
2. If you were severelyinjured and bleeding and were being treated by the paramedicsin
your community, would you want to be enrolled in this type of study?
nYeS
L/J
No
3. If a family memberof yours were severelyinjured and bleeding and were to be treated
by the para&dics, would you want him or her to be enrolled in this type of study?
rs?
Ethnic background: (A)Lk’ ’
Gender: Male
/
Female J
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
9/l 512005 to 1O/03/2005
Pleasecircle your answers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled ,without giving their informed consent?
0
No
Ye
2. If you were sevlerelyinjured and bleeding and were being treated by the paramedicsin
your community, would you want to be enrolled in this type of study?
No.
3. If a family member of yours were severelyinjured and bleeding and were to be treated
by the paramedics,would you want him or her to be enrolled in this type of study?
No
/
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
c?es,
Age: 15
Gender: Male --
Ethnic background:
,
Female 1
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
.
Community Consultation
Empire StatePlaza
g/15/2005 to 10/03/2005
Please circle your answers
1, Would you support a study such as the one describedat this meeting being conducted
in this community~,specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
@
No
2. If you were severelyinjured and bleeding and were being treatedby the paramedicsin
your commtity, would you want to be enrolledin this type of study?
No
3, If a family member of yours were severelyinjured atid bleeding and were to be treated
by the parariredics,,would you want him or her to be enrolled in this type of study?
No
f-62
L)
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age:
7-Y
Gender: Male , f
/
Ethnic background: Id/,
7-e-
Female
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
g/15/2005 to 10/03/2005
Please circle your answers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
2. If you were severelyinjured and bleeding and were being treated by the paramedicsin
your community, *wouldyou want to be enrolled in this type of study?
YeSJ
3. If a family member of yours were severelyinjured and bleeding and were to be treated
by the pararhedics’would
,
you want him or her to be enrolled in this type of study?
Yes J
No
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Thauk you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
9/l 512005 to 1O/03/2005
Please circle your 4answers
1. Would you support a study such as the one describedat this meeting being co,nducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
, ,
No
YeS
0
2. If you were severelyinjured and bleeding and were being treated by the paramedicsin
your community, would you want to be enrolled in this type of study?
No
3. If a family member of yours were severelyinjured and bleeding and were to be treated
by the paramedics,would you want him or her to be enrolled in this type of study?
0
Yes
No
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age:
qq
Gender: MaleX
Ethnic background:
1
Female
Thank you for your participation today.
Pleasecall SusanRauch at 518-262-2828if you have any other questions.
-c
Community Consultation
Empire StatePlaza
9/l 5/2005 to 10/03/2005
Please circle your unswers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
No
(&L---J
2. If you were severelyinjured and bleeding and were being treatedby the paramedicsin
your community, would you want to be enrolledin this type of study?
No
3. If a family memberof yours were severelyinjured and bleeding and were to be treated
by the pamrixdics~,would you want him or her to be enrolled in this type of study?
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age: Abg
1.“.
Ethmc background:
Gender: Male --’/
Female
Thank you for your participation today.
Pleasecall SusanRauch at 518-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
9/l 5/2005 to 1o/03/2005
Please circle your answers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled.without; giving their informed consent?
0
Yes
No
2. If you were severelyinjured and bleeding and were being treatedby the paramedicsin
your community, would you want to be enrolled in thistype of study?
No
3. If a family member of yours were severelyinjured and bleeding and were to be treated
by the paramedics,would you want him or her to be enrolled in this type of study?
es
No
0
4. Do you have ianycommentsor concernsyou wish to sharewith the investigators?
Age: $7
Ethnic background:
Gender: Male’ J
Female
CwL-u;-+*
Thank you for your participation to&y.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
g/15/2005 to 10/03/2005
Please circle your ,answers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled qwithoutgiving their informed consent?
No
2. If you were sevlerelyinjured and bleeding and were being treated by the paramedicsin
your community, would you want to be enrolled in this type of study?
7(-e/
No
3. If a family member of yours were severelyinjured and bleeding and were to be treated
by the paramedics,would you want him or her to be enrolled in this type of study?
No
%/ es
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age: ,!?=?Gender: Male
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
9/15/2005 to 10/03/2005
Please circle your mswers
1. Would you support a study such asthe one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
W
nrolled without giving their informed consent?
0
No
Yes
2. If you were severelyinjured and bleedingand were being treatedby the paramedicsin
your community, would you want to be enrolledin this type of study?
0
No
Yes
3. If a family member of yours were severelyinjured and bleeding and were to be treated
by the paramedics,would you want him or her to be enrolled in this type of study?
Age: Atc
Gender: Male :c
Ethnic background: e *YLL
q:,,
Female
Thank you for your participation to&y.
Pleasecall SusanRauch at 518-262-2828if you have any other questions.
CommunityConsultation
Empire StatePlaza
9/l Y2005 to 10/03/2005
Please circle your answers
1. Would you suplport a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
iYes
c>
2. If you were severelyinjured and bleeding and were being treatedby the paramedicsin
your community, would you want to be enrolled in this type of study?
No
3. If a family member of yours were severelyinjured atid bleeding and were to be treated
by the par&edics,, would you want him or her to be enrolled in this type of study?
No
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
.
Age: L f/
Ethnic background:
Gender: Male --
Female /
A&-
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
9/l Y2005 to 1O/03/2005
Please circle your answers
1. Would you support a study such as the one describedat this meeting being conducted
in this commtmity, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
No
YeS
D
c
2. If you were severelyinjured and bleeding and were being treatedby the paramedicsin
would you want to be enrolled in this type of study?
3. If a family member of yours were severelyinjured and bleeding and were to be treated
by the paratiiedics,,would you want him or her to be enrolled in this type of study?
No
!YC
d
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age: < b
Ethnic background:
Gender: Male -- /
Female
Thank you for your participation today.
Pleasecall SusanRauch at 518-262-2828if you have any other questions.
.
Community Consultation
Empire StatePIaza
9/15/2005 to 10/03/2005
Please cinAe your answers
1. Would you sup;porta study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
No
2. If you were severelyinjured and bleeding and were being treated by the paramedicsin
your community, would you want to be enrolled in this type of study?
Yes.
CL2
No
3. If a ftily memberof yours were severelyinjured and bleeding and were to be treated
by the paramedics,would you want him or her to be enrolled in this type of study?
Q
Yf%S
No
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Ethnic background:
Gender: Male ‘>c
7
Female
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
g/15/2005 to 10/03/2005
Ptease circle your answers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
0
YeS
No
2. If you were severelyinjured and bleeding and were being treatedby the paramedicsin
your community, would you want to be enrolledin this type of study?
No
3. If a family memberof yours were severelyinjured and bleeding and were to be treated
by the paramedics!,would you want him or her to be enrolled in this type of study?
No
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age:
%
Gender: Male --
Ethnic background:
Female
L ‘uJ<
.(L4w~ CL _
y-
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
9/l 5/2005 to 1O/03/2005
Please circle your mswers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
d be enrolled without giving their informed consent?
Yes
No
D . If you were severelyinjured and bleeding and were being treatedby the paramedicsin
your community, would you want to be enrolledin this type of study?
A
es
No
LJ
3. If a family member of yours were severelyinjured and bleeding and were to be treated
by the paramedics,would you want him or her to be enrolled in this type of study’?
Yes
No
0
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age:
a?
Gender: Male
Ethnic background:
Female. /
Thank you for your participationtoday.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
g/15/2005 to 1O/03/2005
Please circle your mswers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their infonned consent?
3. If a family member of yours were severelyinjured and bleeding and were to be treated
would you want him or her to be enrolled in this type of study?
w
Do you have any commentsor concernsyou wish to sharewith the investigators?
Gender: Male -- 1
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
9/l 5/2005 to 1O/03/2005
Pleasecircle your mswers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
Yes LA
No
2. If you were severelyinjured and bleeding and were being treatedby the paramedicsin
your community,would you want to be enrolledin this type of study?
Yes C/
No
3. If a family member of yours were severeIyinjured and bleeding and were to be treated
by the paramedics,would you want him or her to be enrolled in this type of study?
Yes J
No
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age: LJ !
Gender: Male
Ethnic background:
Female /
Thank you for your participation today.
Pleasecall lSusanRauch at 518-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
9/15/2005 to 1O/03/2005
Pleqse circle your answers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
Yes J
No
2. If you were severelyinjured and bleeding and were being treatedby the paramedicsin
your compknity, would you want to be enrolled in this type of study?
r
Yes
J
No
3. If a family member of yours were severelyinjured and bleeding and were to be treated
a&dics, would you want him or her to be enrolled in this type of study?
No
4. Do you have any commentsor conckns you wish to sharewith the investigators?
Age: 2tl
Gender: Male J
Ethnic background:
UJ
/
Female
Thank you for your participation today.
Pleasecall SusanRauch at 518-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
g/15/2005 to 10/03/2005
Please circle your mswers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
wo d be enrolled without giving their informed consent?
No
‘Yes
0
2. If you were severely injured and bleeding and were being treatedby the paramedicsin
ommunity, wlould you want to be enrolled in this type of study’?
No
3. If a family rnemtler of yours were severelyinjured and bleeding and were to be treated
b e paramedics,would you want him or her to be enrolled in this type of study?
No
Yes
0
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age: a8
Gender: Male --
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
9/l 5/2005 to 1O/03/2005
Please circle your mswers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
No
YeS
0
2. If you were severelyinjured and bleeding and were being treatedby the paramedicsin
would you want to be enrolledin this type of study?
3. If a family member of yours were severelyinjured and bleeding and were to be treated
b the para&dics, would you want him or her to be enrolled in this type of study?
No
Yes
0
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age: 3\
Ethnic background
Gender: Male -- J
Female
Thank you for your participation today.
Pleasecall SusanRauch at 518-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
9/S/2005 to 1O/03/2005
Please circle your mswers
1, Would you support a study such as the one describedat this meeting being conducted
in this community, ~specifkally,a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
No
Yes '
0
2. If you were severelyinjured and bleeding and were being treated by the paramedicsin
your community, would you want to be enrolled in this type of study?
No
3. If a family member of yours were severelyinjured at&lbleeding and were to be treated
by the paramedics,.would you want him or her to be enrolled in this type of study?
No
Ye
0
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age:
Gada:
Ethnic background
a
Male
hew
Female /
Thank you for your participation today.
Pleasecall SusanRauch at 518-262-2828if you have any other questions.
Community Consultation
Empire StatePlaza
9/l X2005 to 1O/03/2005
Please circle your tmwers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
Yes
0
No
2. If you were severelyinjured and bleeding and were being treated by the paramedicsin
y ur community, would you want to be enrolledin this type of study?
s
No
3. If a family memberof yours were severelyinjured and bleeding and were to be treated
by the para&dics, would you want him or her to be enrolled in this type of study?
YeS
0
No
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Ethnic background
Age:
Gender: Male --
Female 24
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Location and date uf Community
Ethnic Background
SelectOne
Consultation
t&’ i=W+%‘A rj+pd
tz
S*f*cton*
___....__
_______-__
- _....--._ ._____
__...- .__-.-_-.-----.I -
. -
1. Would you support a study such 3s the on& de&bed
at this meeting being conducted in this community,
specifically, a study in which severely injured and bleeding patients would be enrolled without giving their informed
consent?
G
Yes7
No
2. If you were severely injured and bleeding and were being treated by the paramedics in your community, would
you want to be enrolled in this type of study?
3. If a family member of yours were severeiy injured and Sleeting and were to be treated by the paramedics, would
you want him or her to be enrolled in this type of study3
c2
Yes
No
4. Do you have any comments or concerns you wish to share with the investigators?
i---
_----------
--
Submit
_i_
Reset
a
http:/lwvw.amc.edu/polyhemelsurvey.cfm
g/20/2005
AMC- PolyHemeTrauma Trail
Page 1 of 2
FEEBACK FORM FOR PdRTiClPANTS
::. i
/
Location and date of Community Consultation
I Select one &m&
.-.._-...--- -.._-..__..-_...-.--.
Ethnic Background
Age
SefecZ orI8 n
ml*
ii$
70
Gender
Male
m
1. Would you support a study such as thk one described at this meeting being conductad in this communiiy,
specifically, a study in which sever ely injured and bleeding patients would be enrolled without giving their informed
consent?
0
Yes
No
2. If you were severely injured and bleeding and were being treated by the paramedics in your community, would
you want to be enrolled in this type of study?
0
Yes
No
3. If a family member of yours were severely injured and bfeeding and viere to be ?nated by the paramedics, would
you want him or her to be enrolled in this type of study?
0Yes
No
4 Do you have any comments or concerns you wrsh to share with the investigators?
Submit
Reset
5
Page 1 of 2
TOWN OF COLON-E FAMILY FUN DAY
TOWNOF COLONIEFAMILYFUNDAY
SATURDAY,
SEPTEMBER
17,2005
12:OOnoon - 8:00 p.m.
The Crossingsof Colonie
IMUSIC,FUNANDINTERNATIONAL
FOODVENDORS]
ENTERTAINMENT
IN THEGAZEBO
12:00-2:00The PipeKings
2:30-4:30rb andthe Truants
5:00-890Cryin’Out Loud
FORTHEKIDS
nearthe maze
1:30-2:15and3:003:45Andy“TheMusicMan”Morse
5:00-7:00WizzieThe Clown-master
balloonartist
ACTIVITIES
DARE ‘.
ShakerRoadFireDepartment
ColonieSeniorResources
Veteran’sProject
EMS
ScotiaGlenvilleMuseumCraftsfor Children
.
.
I
.,
.
r~nnrn,~n~,.-:l.~/~n~..~o/.?nn
n.rmAhlrrT
V'X%lFT T
9/16/05
Page 2 of 2
TOWN OF COLONIE FAMILY FUN DAY
ColonieYouthCenter
ShakerHeritageSociety
WolfRd Project
Community Consultation
9/l 812005
Please circle your answers
1. Would you support%study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
.Jes .
No
0
2. If you were severelyinjured and bleeding and were being treated by the paramedicsin
o ~community,would you want to be enrolledin this type of study?
P
\
No
3. If a family member of yours were severelyinjured and bleeding and were to be treated
b the paraniedica,would you want him or her to be enrolled in this type of study?
u\
n ‘Yes
No
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age: 50
Ethnic background:
Gender: Male --
Female /-
-‘&LiL&~
idi
-
Thank you for your participation today.
Pleasecall SusanRauch at 518-262-2828if you have any other questions.
CommunityConsultation
9/l 8/2005
Please circle your answers
1. Would you support a study suchas the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
c
\
Yes
No
2. If you were severelyinjured and bleeding and were being treatedby the paramedicsin
your community, would you want to be enrolledin this type of study?
No
3. If a family member of yours were severelyinjured and bleeding and were to be treated
b the paranmdics,would you want him or her to be enrolled in this type of study?
G
1
YeS
No
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age: 51
Ethnic background T,?,./<<i,c-
Gender: Male-
Female J
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
9/18/2005
Please circle your answers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giviug their informed consent?
NO
YeS
Cl
2. If you were se:verelyinjured and bleeding and were being treatedby the paramedicsin
your community, would you want to be enrolled in this type of study?
No
3. If a f&mily member of yours were severelyinjured and bleeding and were to be treated
araniedics,would you want him or her to be enrolled in this type of study?
b
No
Yes
0
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age: ‘3q
11’3
Gender: Male .
Ethnic background:
Female \
Thank you for your participation today.
Pleasecall1SusanRauch at 518-262-2828if you have any other questions.
Community Consultation
9/l 8/2005
Please circle
YOW
answers
1. Would you support a study such as the one describedat this meeting being conducted
in this comnmni~r,specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
No
2. If you were severelyinjured and bleeding and were being treated by the paramedicsin
your community, would you want to be enrolled in this type of study?
0Yes
No
3. If a family memberof yours were severelyinjured and bleeding and were to be treated
by the paramedics,would you want him or her to be enrolled in this type of study?
No
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
/7d
CL% mLd
o;a4.Lz,
i
,
I..diU (.&A ’ &A I D/&
b4iL~.
L-d+ I+UWL~~.P
Age: a
Ethnic background:
Gender: Male .-
Female g
&XLC+-
z
Thank you for your participation today.
Pleasecall1SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
9/l 8/2005
Please circle your answers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
enrolled without giving their informed consent?
were severelyinjured and bleeding and were being treatedby the paramedicsin
would you want to be enrolled in this type of study?
No
of yours were severelyinjured and bleeding and were to be treated
would you want him or her to be enrolled in this type of study?
commentsor concernsyou wish to sharewith the investigators?
Ethnic background:
Age:
Gender: Male
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.
Commuuity Consultation
9/ 1812005
Please circle your answers
1. Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled.-.without giving their informed consent?
\
No ’
c I
2. If you were severely injured and bleeding and were being treated by the paramedicsin
your community, would you want to be enrolled in this type of study?
YeS
a
3. If a family member of yours were severelyinjured and bleeding and were to be treated
by the para&edics, would you want him or her to be enrolled in this type of study?
r i
No
Yes
d
4. Do you have any comments or concernsyou wish to sharewith the investigators?
Ethnic background
Gender: Male
Female
I/
Thank you for your participation to&y.
PleasecalllSusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
9/l 8/2005
Please circle your answers
1, Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
YeS
No
c3
2. If you were severelyinjured and bleeding and were being treated by the paramedicsin
d you want to be enrolledin this type of study?
3. If a family member of yours were severelyinjured and bleeding and were to be treated
bytheparam ‘, would you want him or her to be enrolled in this type of study?
No
Cl
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
YeS
Age:
:
Gender: Male
Thank you for your participation today.
PleasecdU SusanRauch at 5 18-262-2828if you have any other questions.
Community Consultation
9/l 812005
Please circle your answers
1. Would you s~~pport a study such as the one describedat this meeting being conducted
in this commttni~y,specifically, a study in which severelyinjured and bleeding patients
emolled without giving their informed consent?
injured and bleeding and were being treated by the paramedicsin
you want to be enrolledin this type of study?
member of yours were severelyinjured and bleeding and were to be treated
would you want him or her to be enrolled in this type of study?
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
%
Age: ’ ’
Ebcbay:
bidi:” /
Gender: .Male
Female
.
Thank you for your participation today.
Pleasecall SusanRauch at 518-262-2828if you have any other questions.
Community Consultation
9/I 812005
Pleasecircle YOW answers
1, Would you support a study such as the one describedat this meeting being conducted
in this community, specifically, a study in which severelyinjured and bleeding patients
would be enrolled without giving their informed consent?
No
2. If you were severelyinjured and bleeding and were being treated by the paramedicsin
your community, would you want to be enrolled in this type of study?
No
3. If a family member of yours were severelyinjured and bleeding and were to be treated
by the paramedics,would you want him or her to be enrolled in this type of study?
Yes
No
Q c
4. Do you have any commentsor concernsyou wish to sharewith the investigators?
Age: Jt9
Gender: Male .-
. u\ ’
Ethnic background: $ii%%
#
Female
-+
Thank you for your participation today.
Pleasecall SusanRauch at 5 18-262-2828if you have any other questions.