Download document 8881470

Blood Substitutes
Baxte/ Healthcare Corporation
Route 120 & Wilson Road
Round Lake, Illinois 60073-0490
847.270,5300
Fax: 847.270.5306
g-”,.
i3axtf3-
August 5, 1997
Docket Number 95S-0158
Dockets Management Branch (HFA-305)
Food and Drug Administration
12420 Parklawn Dr. rm. 1-23
Rockville, MD 20857
RE:
Investigational
New Drug Application
#6859
Dear Sir/Madam:
j--
In accordance with 21 CFR $312.54 we are enclosing a copy of the information that has been
publicly disclosed by the Institutional Review Board (IRB) at Parkland Memorial Hospital, Dallas,
TX, concerning research involving an exception to informed consent. This includes an
advertisement that appeared on April 13, 1997, in three local newspapers, The Dallas Morning
News, The Dallas Weekly (Attachment 1), and El Sol de Texas (Attachment 2); an advertisement
that appeared on June 22, 1997, in the same three local newspapers (Attachment 3); a press release
from April 16, 1997 (Attachment 4); and a press release posted on the Internet, on Parkland
Memorial Hospital’s Home Page (http: //~.swed.edtiome~ages/parklanWpr/dmgtest.html)
(Attachment 5). In accordance with 21 CFR $312.54, this information is also being submitted to
the IND file.
Based on information received from the clinical site, the investigator and IRB achieved community
consultation by printing advertisements describing the clinical trial and the product in local
newspapers (Attachment 1, 2, 3) and including a telephone number and/or an address to allow
individuals to provide comments and ask for more information about the product.
If there are any questions concerning this information, please contact me at (847)270-53 13.
‘7>’4
n
K
,%
Maulik Nanavaty, Ph.D.
Director Regulatory Affairs
Blood Substitutes Program
L
DEPARTMENT
OF HEALTH
AND HUMAN
PUBLIC HEALTH
FormApproved
OMBNO. O91O-OOI4,
Expiration Date: December 31, 1999
See OMB Statemenl on Reverse,
SERVICES
SERVICE
FOOD AND DRUG ADMINISTRATION
INVESTIGATIONAL NEW DRUG APPLICATION (lND)
CODE OF FEDERAL REGIJLA TfOIVS(CFR) PART312)
(TI’TLE21,
~
2. DATE OF SUBMISSION
1. NAME OF SPONSOR
Baxter
NOTE
No drug may be shipped or clinical
mvesbgatwn
begun unid an IND
for that
investigation is in effect (21 CFR 312.40).
Healthcare
Corporation
08/05/97
120 & Wilson Road
Round Lake, 11
60073
Diasp~rin
Crosslinked
.—
4. TELEPHONE NUMBER
@dudeAreaCode)
3. ADDRESS (Numbec Straet, CIM SteteandZip Code)
(847)270-5309
IND 6859
Hemoglobin (DCLHb)
7. INDICATION(S) (Covamdbyfttis subrnisAn)
Treatment
of Severe Traumatic
Hemorrhagic
Shock
E. PHASE(S)OFCLINICAL IN’JESTIGATION
TOBECONOUCTED:
UPHA3Ei
iJPWE2~PHASE31JOTHER
(-%-%’1
9.
UST NUMSERS OF ALL lNVESTIGATfONAL NEW DRUG APPLICATfONS
&f C/W %-f 3/4), DRUG MASTER FILES (21 CFR Parr 914.4?Q), AND
TO IN THIS APPLICATION.
(21
CFR
f%l
312).
NEW
ORUG OR ANTIBIOTIC APPUCATION!
PRODUCT UCENSE APPLICATIONS (21 CFR Par! S01) f?EFERRE[
IND 4426
IND 6859
= INU submission
should be consecutively numbemd
Zbe Wtfaf IND shwld be numbered
“Sadal number: 000. ” lhe next submksion
e. ~ amendmeng rqoo@ or cotrespondencej
JO!
Subsequent
submksfons
should be
should
be numbered
“Serial Numbtm
numbered consecutively in the order in which they>m submitted
1.
THIS SUSMI
B
ION 00NTAINS THE FOLLOWfNG: (Cha&@that ~)
INITIAL lNVESTIGATDNAL NEW DRUG APPUOATfON (lND)
‘ROTOCOL AMENDMENT(S)
n
SERIAL NUMSER
015
———
RESPC44SE TO CLINICAL HOLO
INFORMATION AMENDMENT(S):
IND SAFETY REPORT(S)
J
NEW PROTOCOL
❑
CHEMISTRYrMICROSIOLOGY
O
INITIAL WRITTEN REPORT
~
CHANGE IN PROTOCOL
O
PHARMACOLOGYiTOXICOLOGY
D
FOLLOW-UP TO A WRfTfEN REPORT
~
NEW ff&’ESTIGATOR
H
CLINML
J
RESPONSE 70 FDAREOUESTFORINFORMATW
Public
Disclosure
or Waiver of informed
❑ ANNUALREPORT
3 REQUEST
FOR
REINSTATEMENT OF INO THAT 1SWITHDRAWN,
n
❑ GENERAL ODRRESPONDENOE
OTHER
iNAOTfVATED,TERMINATEDOR DISCONTfNUED
(%=W
CHECK ONLY IF APPLICABLE
%., ..
lUSTIFICATION STATEMENT MUST BE SLfBMllTEO WITH APPLICATION FOR I@ CHECt&
,:
)ECTiON FOR FURTHER lNFORMATKfN.
~TREATMENT
IND 21 Cl% 312.35(b)
D
Consent
TREATMENT PROTOCOL d CFR 312.~a)
. . “ri
.
,,.
..
B~OW.
REFER TO THE C$TED CFR
C@t%~}REQUEST/NOTIFICATION
21 CFR312.7(t
..’
FOR FDA USE ONLY
:DR/DSIND/DGD
RECEIPT STAMP
I
)DR RECEIPT STAMP
-—_
INO NUMBER ASSIGNED.
ORM FDA 1571 (1/97)
PREVIOUS
)
PAGE 1 OF 2
EOITION IS OBSOLETE
!
rr
I, 22..=,
CONTENTS OF APPLICATION
contains the following items: (Check all that app@)
This application
~
1. Form FDA 1571 [21 CFR 312.23(a)(l)]
J
2 Table of Contents [2? CFR 312.23(a)(2)J
I
3. Introductory statement /21 CFR 312.23(a)(3))
J 4. GWWS1
Investigational
plan
-Igatots
[21 CFR312.23(a)(3))
brochure [21 CFR312!23(8)(5)J
I
5.
~
6. Protoooi(s) [21 CFR3t2.23(a)(6)j
u
[27 CFR 31223(8)(6)J
a. Study protocol(s)
D b. Investigator data/27 C~3i2.23@)(6)@,,(b)jor
completed
Form(s) FDA 1572
❑
c. Fadfities data /27 CFR312.23(a)(6)(i#(b)jor
~
d. Institutional Review 8oard data [21 CFR 312.23(a)(6)@#(b)jor
completedForm(s)
J
7. Chemistry, manufacturing, and control data /21 CFR3?2.23(a)@)]
~
6. Pharmacology and toxicology data [21 CFR3t2.23(a)(8)]
~
9. Previous human experience [21 CFR312.23(a)(9)J
n
FDA 1572
completed Form(s) FDA 1572
Environmental assessment or claim for excfusion f21 CFR312.23(a)~)(?v)(e)]
[21 CFR312.23(a)(10)J
~10. AddMortal reformation
PARTOF THE CLINICAL STUDY TO BE CONDUCIEO SY A CONTRXT
3. tS W
RESEARCH [email protected]?
~
❑ NO
S=VES. WfU ANY SPONSOR OSLIGATfONS BETRANSFERREDTO THE CWTRACT RESEARCH ORGANfZATION?~
YES
FtEswof
IF YES, A1-fAofi A STATEMENT C0NTAfNiN(3 7t4E NAt4E ND ADDRE3S OF 7HE ~a
ff THE CLINICAL STUDY, AND ALfSTINS ~~E
0BL@4TfONS TRANSFERRED.
6859: ()()()
~-
c
❑ YES
~ANDTln.EOF
WPERSON
RESPONEW-EFO
RMONfTORlt@THE
wEsnGATfoNs
Robert
lled~cal
J. Przybelski,
Director
S w)&#lll~
~
ORGANIXION.
~ee
Im
AND PROGRESSOF THE CfJMCAL
M.~.
OFTHE PERSON(S)RESPOf4SlSLEFOR REVtEWAND EVMUATfON
OFtNFORMATtON
RELEVANT
TO THE
Robert J. Przybelski,
Medical Director
M.D.
1agree not to
begin clinical investigations until 30 days after FDA’s reoeipt of the lND unless I receive earlier notification
by FDA that the studies may bsgln. I ●lso agree not to begin or contlnw clinkxd Investigations covered by the IND if
those studies are placed on cllnlcal hold. I agree that an Institutional Review Board {IRS) that compiles with the
M@@JM@S * ~rth
In 21 CFR pan * Ml! b$ =@nslble
for initial and tindng
review and approval of each of the
I agree to oonduct the Invaatlgatlon in accordance wtth ail other applicable
studies in the proposed cfinical Investigation.
nsgulatory raq uirements.
Is. NAMEOF SPONSOR OR SPONSOR’S Authorized
REWESEMATfVE
J. Przybelski,
Medical Director
Robert
m NxmEaS(N-.
-,
17. SK3NATURE OF SPOHSOR OR SPONSOR’S AUTf+ORfZED
R
SENTA
M.D.
&
B
w
w. Samand+ @C%)
19. TUEPHONE
NLM4SER
30. DATE
-m-)
120 & Wilson Road
60073
Round Lake, 11
(WARNINO:
PM
A willfultyfalse
statement
Ls a
<847)270-5309
4
crirnhal oflenae. U.S,C. Tii
31%
18, ses. 1001.)
m?porfing burden for this collection of infofrnatiin is estimated 10 avenge
100 hours per response, incfudhg the time for reviewing irist~,
~
existing data sources, gathering and maintainingp the data needed, and mrnpfeting revfewing the collection of information. Send mmm(
Jmg Uus burden estimale or any other aspect 01 this cd ectmn of inlorrnafii,
In&ding suggestions for reducing thw&?n to
K;’%!XR!X%%%%’KW014
f4&;&H;;[;~~~#c!k!c@~m
Washiion,
OC 20201
j
“An agen~ may not COnduct or sponsor, and a ermn is not required to respond to, a mlfectiin
of mforma Ion unless it displays a currently vaht OMB mntrd number. 531-H
Please 00 NOT RETURN this application to this address.
FORM FOA 1571 (1/97)
PAGE 2 OF 2
,.
–——
——
RdlikJlndlTitmlllnrna
celr!iliklf!oooo
‘
to Test New Ichg
,
-
Bloodprodua may save lives
~
MmtialHospitalis among35maja traumacanters&t areevahtiag a MWtnwmantforaiticallyinjured
patiaM with severcbloodloss. The tmtment involves admkMdng an ~~wd~t
@~~ @-1
w~ *
as@OSIiSk Of@@ d%pk die k$t mdkd -.
@SS-~~
Ba.xterHe.althcasq
k., has deveks@ tbePtOdU4 ~treatment
of
tmxnapatknts
in
shock
Tle
ti
which is
dm ~CDXFXKV
_O~=~O
w~~is fig **
audmzedbydieU.S.FoodandDrugMmdstra do%rtqukes poblicnoticebecauseit willoccuruodercmmgencyconditions
thatmaystqoire anexceptionfrominformedcansett Thisnoticeattemps to addressquestionsaboutthetrial.
Wi3willmakeeveryaaem
or frostily
A
DCLHbmis ghm andall phsta and
members wiU becos@@y infcartedof rhdr partklpndon
stsiOuslyhlJusedp3rhlasf@quendysdwiuthehospitathsottock
, thdrfhily
wkha@d5cmtbtoodtsw Desphcdsebcsrsarcs
ne&tnebastoc@x,as
Maapw
my=a~dtimwd~yh~pauwtieh
to obtaincoruemfrom
patiem,rbeirle.gal
L
repzwntatiws
Adl*tiptior
tim~s*tiwmy
.
--pW*[email protected]
dxiTkajUrk&studies
mggeSrtbstDcUib"
msyisnprovether&aceclf
pedsmtaWbodecide llottocohuein
[email protected]@chassoa
afkp@tg
aowivalasdrcdudssgcomplications wtm it is given
he Srody.
shockandblrcding,
hmodmu& atithcbcgistning ofcasasrsophic
A
Da.Hb"tsasbeeusateosivelystudiodiorarldosnizaduiala
kWolviskgrO&e
tbaat700 padcrmoverafour-ycarperiod to evaluate its
mdbaamks$ ydlowing of dla &in(Uruelarad
10
M-@WJ~d-tititiG&@tiedmlwof
indudi”i,gDCMP. atttu~ md M abdomiaalandmusskpsin.
ntwmd d heasedreredustbe Sisioftslood-bodhtfecrioaa
Blood
Am6. Duxb~maysesromblood
5us14iacreistMoodftowto
praamra
rnaY
bafollowing
adosialsmtion:
bowcvu,tb$smay
blood @g
viralotgXssandcqeMygerImCer andtiSStSC.S.
babadcaal wpatuntsmshockwbosabloodpreaaweisdangerbualy
tesr-ksulia,
t Unprary
iaaotsa@redmdhaproducrsanbestoredinthoEmargaacy
DcLHw -be
giveu knrncdatcly afsa s patiem’s
*&wlngcddcal
momessrs
iassabilizing a Ualssnapariem
Q.
D09S~m
A
DuHb~iaashdnkdindditiontotra&udwmmybe
9
I’@@thellCCdfOfbloodtransfusion?
oeedetftotraatthoftajurcdpatiorIL(siithcptoducti$snadetiom
bmmttWo4itwddnotbcsuirnblelaueadngp3iMrswbose
reli$iouabdief4forbtdbloodcra@lsions.)
PuientsWitlstiltgatau
stsmdadtbe@ca iaddaStudy,isschdillg
Moo4fluldsandaurgary.
AM@.@lDCLMbThfrnty
Sedllcedle
nusnbarofbloodOansfudoas
rm-tibjumd,vohm=bloo
ddontions ~atill vital.
Ixpcrrs
winsnonflOcpllrbcSdcry
dsmughourdteWiat.
low.Iodepaastont
Paaidandla pmidpadasgin thisdrugUid because
be lvmedtsSo
maygrc.atly
W~5tUWSInXPa6CnU
Q
s
e.xcd
know
side effecu
Wbowill be eligible
topardsipare?
Wkb iOW bloodpm.swraaadin attosk
@K5Xh*y 3opUi0tltS
A
flomblood tosafcdlowiagsraumadcinjutyW ba ensollodu Parkland
halfofthoscpadessts
WW
owdm next 18month.~JdSndY
IadvO b
blood productalor$ With ok
Et4Lmm!
Thh
product
Will
bloodIMSthataundard
tkaPY mw StOtbCCiMJ#ttO
WCWrlives.AtoratofMOpatients
baghta
tdy
@ psttkatt
WhO&VS
$uch usqjor
will boemnedrtuioddeat35uam
nacenws.This
mid isbdslg
parformedtmderdbagtaiddinesandapprovatofttwInstimtiondRAew
.
A
Becauoerrsumaprieats
areaftensoaevrrdyissjure4theyrnay
Mb~to#veti~mw@dpmintidmg
tiLStiU&
Beadofl’beUniwmicyOfTWLM
SotstfIWessem
MedicalCuttw as
Datlasd tkUS.Pood mdhgtimlalsmtioa.
No addirhssd
chargotwill be ineorredbypatientsast tit
ateincaidcdtwdof
immdaSetsaatate?lLTbaus
FOOdadDang
&ds&radeabaa gr8atcdmaexCcption
fMlinformadooateatiosQch
the
~lbcY
luwtiyevalnati
DCL.HWanddetamhd IJASU
potetitial!xnetW greadyoarweighthe risks ofpatrkipasing!n ha oial.
k asesok psdentsntayk earollrd in W studyand redveDCLHbw
what
ksfomd
cmsear
is riot possible.
g
~
w
Parkland Health & Hospital System
5201 Harry Hines Boulevard Dallas, Texas 75235
\
.—-
ofpardsipation.
N
ml-NmN12
de~rauma
(kRt~O
_
_.
pa
de
pdda.nd
Ulma
moga
.
.
~arii
Il?mebm
I?4ueva
Unpmducto de h sangre ~uepodrtu salvar la violas
Mcmc&l Hospital@ c@eIos35cmtros& trauxna&h@@esqueestdncvahandouo tmtamkntonuevopas-a
PaxMaMI
paciellteshefidosCdticaumltcconunap41’dkh&sangreSCVCG+
El (xatamiCnto
inc~cl Up*onpmduoto Cxpcdmeutal&
_AoSdW~~$:~,_
a fhgo mayordexnor@ a
y..wmdob.&9%?zFti%*s”g2s?a
natmniwUo&
crncrgenciacn spacknmsdem
mmaquccsth:cae stado&ohoquc. Eicxpmi.mcnto,
elcualc#autorizado
pus FoodandDnlgAdsninistratiors
@dminh@ 611deDrogasyAlilnnnco$& B.U.),requiere
denotid.a
p61MxporquC
OeUrrMbajOCOndicioncsde
“ quc pucdcn acwasitzmu~ cxcepci6n& la informtu2i6nde autoxizack%,Em noticia
intemadi@rsealas prcgunS&&%ntene rsdxedcx@mento.
obK!oas
11ilformscido
autohlda.
Hamsnos
106010
poaible
pm ckwnerla
fonmdeworimeidndolos
‘coh%desossqmmnhlegalmo
desufaxdiaamesda ueksapliqwn
I 0s
y all!kmilissStrAn
loformd
R Coofkueochllegonii “tdpacimbaa
boridomoy
Slxiammlte
yco r DCLHw,y todosL%padcnrlx
deSUpS1’OdpllCidU
WIpfOhIO
qUC
seapodbk&I0)60
“% SaDgICnW
tigoif~uiA~r6cl mjor fXSS@CMUWOle
esudodeohqucoulUoap%lidl
memento,
elpackuteo aumprmmtantc
pucdcnagmeaunapanitipacidn
ooiMo~olkcah_lamyrdsdeoa40%dclos~outatsxi60s
d @&a Now aabcdtrioagos
paralospadentesquedecidanno
fhOJMCSI
tiddcanscntelwirirldcssxbaidaa
Loa@16ie4u@mll
ooathar cond oahdio.
--pne6amtjorarh.tiidc@mMr6Gm%srkm
P
, @xq&secsKbash60dqksosrsto?
damlgx$ellcra
Hpmdsremdcnehgmnp4aibiidl%jonrh
amsdo
aaapIicawimamemc
mbmiwoca yrd0c4rlas Corllplicxhua
@& empltzllrd
caaswico* dcdloqw
yaaogrambuw.
P
~.
P . @@s aon104rirsgos
ycfcuosWuntios dclt DCLHbW
R
I.#DcLHb~a aidocswdlodacsneamn@ccn
“
C4a)alos
quahldoycnmwOOp”mtmso
wnf!e!f@3a&ap.m
ladmga,
evdlsarauacfdoa. ApnXlluadammudo3s0pbdaltca$wgC.iJcm
@sdcalmcLHbw
*OwvuOrturSScosnros
efectoasLv31ndalios
K ~msswcstmowtw-(u~xalamqoc
‘%%amadlotem 3
arnbiosanalguooamdhdOsdalabomroIiO,url
_llcvad@eao)osr)napropmcidn~sslwahtagmMoawnsfccha
pklqrsanobcdafio(noUeaerdtd6ncooda6oalM.gado\aamjdmis0t0
bsncodesaf@cyya
~pl?c6c
-#g&&’= mcrIeqntoloaeatmreSdd
aon
enla
tusrpmlmlaodoadebidoalcokrqlodclaDCLHb~,odusqdoLx
fnnsbow Sofilmymakuapmadudrd
Lapreaidodelaaaqre 8elevarat
abdomid=$
ealaeapdda.
infwdoaoaqqnmdacanwhssqmindaycwbclSIdA U D%&
euopodrfaser&
bale%!! 10s
J&“aincmbarg&
sJaabkelaprddlldolaaalsgrqmKslraltcoakatetklaaangmsloa6fgarloa
dmenhp@6mdelaaasyxr ‘groatmcwc
-yllovadoxfgonoalasadldasyabatejidfw Poqusnomqsktedcun
F
dPo*SmSmYdpmdwopUadagUardM=eod~mde=wtlcia,
%
&dk=+E%&22:%2%5:%!E!J!%’3$%:
klxirmJPJpoede@Carst
iamediatameorc
despossdelSe@fel
psoie%
prMquebsbeaeMoaparalm@acesdelmsorlqlucs
Inommms-paraesmbillmrlonpadcntodcfnum
teveMMepQdrfanesYxderbWanElos&lossecundarlosddeammell
,
P . @nedarw@azariaI%XHb”hnacddaddcuamnsf&6ndemngre?
I
R .LaDcuibweqlk4adeto$delaasmdudo@
—-$v--d--,
O’qJCE=:S~U-JC
w_mwI+no$er@@dopmuaoqa
P . 4*
Sadd%ii pmpardaipaf?
.
R
6drI#%%*AM
doa18p&Ma&aaogredoapo6sdounabenda
&“w~”@”w’”””yw
fmlrrrsdrkaawhregbdosen
ParMaodeakSs
prdSimoslgmeset
AproJtirnadamcntciamimddeesroapackflre$redbird6dprodModclasulgm
dwls’’~+=%%szz
rggw
*
jorltocortocrommmkuo.
E#opmductosolansootcaelos$jrbSrLtlos
=*Y~&~YC
AUOW ~~M*d
-da
pacteotaaqrralmgaosroapdrdidadc$allgmmayoryfarqSiarkmnalriopodsfa
st~”tmpmtramrunahori~ laadoaaciooaa sarsatideare$msawarm
vid~ WIW desS0pacierms
$@ tegistradoa
Mc@riasdcsMCrem&sigumdasldomuyimportMte&
ensodsls*6nmS5&r&osdemomLE$re~”mlxlross@haoioodo
bqjobsl’CfbUy@b9Cida
ddhdutiond biowBoardoflhoUnhmcdtyof
P . @dC$0Sa_&laio*6aw!
R
orid9yporqMaswcesaria?
~~wostmMedcd
CaoWahsyhU.MxdandDmg
ddmsMkm@rltdhctivddLcMoInd@d+dsurIivdty
Ofrhxas
x22%%5#3’x2mgKJt22’;E&&%62L
lkMo IqoccoIllksMlclabapulcsltc$&rmumaescsaacddoalnuy
adradodaso@dp@6n,
SUwmam$yaopQtdeadu$rlao~ pmpWtlltl~
doladqa..A6nad$elawasidadctfrkapmonlntam@oimnedialo.
La
MrdrdmhdeI)sO*y Alimeotos&&u.(u.&
PoodaodDmg.
Noaormscohkhnd@araomamw
Omumossobralawa
iWdaddcauoel
%2252xt%!%!!’2i%%%%&&2%5%!k
y
haadeemhdo qlx&poaMidad&)asbcaemoac$rnds~yposilmk
~h Ii+gOSdepmficiparm
d oqorimmto.C&nomauhado
lospacicntes
~W~mCSwC@610
yrcdirltDCUWcmdonoam
poaiblc
?@
~
ParlclandHeaRlj &Hospital Syskrn
5201 H~ Hines Boulevard Dallas, Texas 75235
\
/’-
Ti’mma
IP!!bddlalrnd
c.%::’”
to Test New IDrwlg .
.
_
Blood~mduct may save lives
Memorial Hospitalis among35 major
WMaM
@entswithsevaebloodloss. I’hcm@tscnt’
am$orrisk of dyingdespitethebest medical
WObii
(DCLI%”), which is I&
BaxRx~bbas&vcIo@
thcptoducLDiaspirin ~lixtkcd
&~q~tofhm~timhsMm@,wMdk
“
tested
“on,requirespublicnoticebecauseit willoccurunderemergencyconditions
L-rhistwticcwtcmptstoad
dnssqucstionsaboutthchid.
UXhonzdby$he U.S.FoodandlMtgA “ ‘
4
-mayroquimancxceptionf iominformd
Q
●
wna castcn fhatamdusting a newmxmcnt forcriticallyinjured
auaqmimenralblood@UCt tosuchpatict@ who &co
lvuadmink@
Wbyis?hislrial biagpafontd?
Scriouslyinjltrcd psricats
kqucnlly Sn’h’cu tk SpiulisStink
A
wirhsignificaotblocdk Despietbobcstcarcmedir&%$ tootf~at
srtaayas40pcrcatof &emostcritidtyinjuKdpricarS “ dbsfK4m
lkdrinjurkS9ssudi(!4
wggsstthst DcuWttlxyimpKW
d!snc8d
aurVHfolloWiqseWC bforJdlosLlbcpmduubssthc
-_
.
brsirlconseutftompatiwtMr!egd
wewiltmskewetymcavJtloo
~m fi@w.~
~lY ~~
d Pstkntsand “
. tbsirfbtnilymmba’s @ be Compkly “hfotmcd
of sbsifpu!iciptiotl
uwotlaspwsiblo. AslftirnCs!thCPukmofrk
krCwescat.uiwma Y
dodIQsfwitiotpdoipstion h tkl stiufy.Thesem m-knownrisk to “
#’-
-f@-
~
p@J=**notmcoalitmc
inbdy,
ofbpwvingswivalmdtcdudmlwm@iMtiooswbmit”giwo
~**_gd~**k@
-g.
‘cl Wb4stotb!e
Q
Dcmb”bssbceasxtiy
$tudisdiarsndomi2dw
AL
[email protected]
eff&l%oftbc$ppfoximstdy350witonxcivcdthedru&afow
●
wbuis
QcLHb=?
.
● Dcuib~&apuritid
bm@obin(sboprsofbl
A
CMSkSOXypa)prqsrUioa
msdctiombutnmbioodthat
$
‘amd-ioabloodbmk
sbclvssmdisaolongszstssblc
kia61tessdmd btusdmmdulXtk tiskofbk&bomc
it@[email protected]~
Dcu DUIibm+cethcswad
mnsfa&w
‘
t$odd
tkwsotiulorgaas
sndcsnyoxygmt6colls attdtiwu=
t3@ngissvXqsirsdmdsb
cpmductoanbcstow iintbc
-L
DCLHb”csabcgivsa imrncdiuclyaftora
aw4agoriticxlmomcat$ iasmbil&garrxualapuimL
Q
m
*
tkat’c=%al
Sstqmmyd4kefketsWml
[email protected] ludodobMgcsiasom
clab
tutrosul%atSmpmtymd-yeuOIMngoftheskh(UtmlUedto
*-hm~*mgof*
*&wtid*lmof
DCU’o%mauwa,xndkksbdominatmdmusdcpsin. Blood
P=XWb-d—gd$mnmr$.
;
bmctkld m $stimtsin shockjwhoseblti =~=~j%
Upcndmt $zpWswill morlilorpmkmsaf* tbrougknsttitstl’ixl.
Fwklandkpat+dngintisd
tugtrialbwauwthebmofitsso
~=palicmsmy grdy cJwocd Imowrl
Q
Q
~w
Ik Immberof blood
wlun&crblooddoustiotts
atc dllvital.
3
● wbuisutsXecpdOtI
=-$WY?
side cffcus
-2
Q ~
Witf be
eligibkto~t~tc?
A
A#fwh@y30@mt@tbbwbloodp
rswurc$ndkt~
ffombkodlossfoifowingtrsumsrickIjutywillbceaTolkduPsskl8nd
bdfoftbc$e~cars
will
mtituxt
18tomths.A-tely
soecivottsBbklcnlpso4uctdongwktlotlur ttuttnmt. ‘M psodumWiU
bogivmoIllytopsdmts wbohsVcsucbr@3rbl@dlos$ tbMsssn&rd
~m&Mh_@aWtiliSAtiof8W~s
wil!boostlOllod
MtionWidest35
trslunscmtemTbis&i8lkbcklg
porfosmsd
undwtbc~“delincsmd xpprovxlof the ktitvthsl RJZ+CW
fiotniofomedcowmtmd~isit
Btcauwrxmnups&uts
sfcofbmwwvudy.
lib
aw3em*!eto’eeco
nsflMto panicipsw
intkcdntg
BoudofTbt UnivasityofTcxuSouthwes&mMcdicdCcatau
*V
m Sti&lbsy
UeUmmt.
Tbcus.M
.
AddtUSmashSS
grmtisnexce@Otl
&lOmiQfOtmd
aSS&Tbcybsvc
OarcfUffycvSIUStcd
DcLHbmmd
S&%$
-~**Y~~a**of
“‘ “ ia&tiw
AsawsulLp&atsms
ybtauoucditlthk
d
*
istfolmcdConsca!
isml possible.
L
of DcLHb~?
for blood twnsMon?
● DC1..Hb-”kadnkksd
insddkioato
“
A
bol%edcdtotrcsttls ciajdpsdmt.(sincodloproducs.
ml&&&y
kwnbloo4itwould
notbcsuiubls iamss&lgpuiotlts
sdi#ousbslicfsroeoidbbXJdmlsfusiou&)Pxtiwn2win
gad
Smdard shcrapicsfn rhkpdy, inchsdiagblocd. !lUi&
SqcJ.
+ti
-“,yY
$equue$to=tU=sojm&
rishuvlsidedfau
d
Dsllasmdtbc
U.S.PoodsodDmtMmmmdoGNosdditionsI
‘.
dsssgwwillbinamsdbypslimtsssaresllltofpsnidpadow
wcuP$CUmdac.xCitai
sbouttfupOmukl
lhssprodwsl$uclls
DcL3ib'mxyksvsto
mtolllysaYslivabutakotomftndtksusdll
Iifeofawxyscars
[email protected]
=$mPkOfb--.cxp$ad
tbcssfctyaadkls
==@$~wbybm~*@&$Imhc@s$wth=
sltothcr
—
To provide comments undfor mo~ inforntorion
abour this product, pleuse call 214-648-5430.
Par$landlIal*&EI.spitalSystern
52 1 Wny nines Boulevard D~l+ Texas 75235
-
-P
##-z
000-000004
.-.
●
P ● A
NEWS TIPS
R
●
K
,L,A,N,D
NEWS TIPS
NEWS TIPS
April 14, 199?
FOTImrudiate klooM
Contack Swan K Wilson
work (214) S9Q-&)~
Pap (214) 7864527
New drug ttatd
-
OU
rntidiy iqjumd tmltfna
@cnts
DALLAS-P8akkd Walth & WSpital System’sTkaumaDopar?matis one of
?Xirnatoly 35 sites tostingancwdrugbit mq helpszwcb WCSofsomcof tie most
mtkttlj y i@uui tralunapatiults.
~tiy4pt&dl*@mb*
=atitd&tidwmbl@
105s,dospk the best medd cam available.
~enmhgkabld--h-h-~bld~s
-~
in a ~l~tione ~ ~ x
~ b ma =wJy injti patientsu major
txaurn?oen,tcrsacrosstbe oouatrycopreventdw harm!ideffectsof were bloodloss in
iSiuuMK&xedbyMxtorXcaltbcarc
Ccqoration’s
IMZKIXS.
The bkxi pSUCW
Bloo Wxdtutcs Dtf&iiOsi.
Y
.+VXXX
MOpatierm who am at W ofdyiagfromtbcir rn,es willbe part ofti
nadonwidetrial.Bcoaue of the c&W natureoftkit rnjtiq few Many of thesepatients
@hqlcd#*MdmmtMm*~h*rnid
Mof-xmsa-wacq,ti-wtiumcao
solution.
TIK3c patietxsab
will be giy
&loImUyusedto &at shock
RWdnlgise
Hemo@bin@CLHbT
a+ Odierstmda@
lc$E%P@du’bM’”+~~~”-=
#obut solutior.adkd LhspmnCTOSS-LJnImd
,wkhhaskmutbod;dforti@tes@bytieF
dtid
~MmkWationaiterf6uty
emfhumauciinid&iddnvdv@mmti7@
iUCIU&#
139shock aud -~
“ef~.
ptiCTdS,
Sxuh
help Sbbii
to tho mostseverelyinjured
traumapaficms
to
win b Uimhistercd *
Silook andimyOvO paliult OutcOml UcOdhlg IOIX. David Pmv*
chief
ohioal invcstig#Orforthc
dtug*&%~~@lh@4nt
Univdty of TexasSadmM&m
~SOhJtiOtliSI@C~OU-OreX
prO&SOrofnqq
‘
ti’lhe
inxma~~oodcoils-ljloti
supp[iesdaatwouldothemtkbemmovcd fsom Y loodbanks8nddcsuoycd.lnstea&&a
new PKXCSS
ckvciopcciby BucteL the bloodis tma&dtoremovedu bmogktbin,the
m&w=y@
~mpm-f~blod
fkomthebkxxi ds.’rhenit is
doestlqcuodtobecmss-matcbcd8r&dcan#@yk@Jfcdi,n
itnmccUouseinthcmOaakicaltfauma~,(Wcedtc
%KRL12
P ‘giousboliofsforiidbloocl
bti d wouldnotbe sMaMehtrWngp@caG ~transfuJoOsJ
-rhenew~=*wti@ete
45-timhtintitia
[email protected] cxamplGmatddngtlwviodm’abloodtypewithbloodbank
suppks m * aslongas45 minutes.
- bloodloathecdls amdepnvedofh
Wwxlpasial@bavcscrip Mlmatlo
Ix@ 10 d%” Frovostsaid.‘Their bloodpsessurc
Oxy@idod bythehemogWn UM3
drops,their organsb@u to (@ aad fti:l,theF:tk!dies.:
Thconlyway tointcrvcne inthisprocoss ist.o~
Ymphm the bloodthat
caries theoxyg#=nch hemoglobinto the celis.
DCLH?J can be given to a patiait of any bloodtype withw May, sum it
contains My the hemoglobinfrom the blood cell, ncxthe andgcnsfound on *6 sutfaseof
-’-m-
000-000005
NCWdmg — add Otx
the cell. The hemoglobincarriesoxygow andmay improve oxygen dclivcg to the organs
@need h mom help rem
the ~Yc
ticda of shock and save lives.
Becauseof thecziticalna(uxeofthia ~=ofqnqency,
t% FDA hasgmnwdan
cxcc “onfrom infofmai comontnormall
manewdtugstudy. tisoonas
~ r ble,howevur,the~“ent orthe &y*
bcmfbnncdofthestud yandcandocideif
theywishto continueparticipating.
Parklandwaschosen watestsitc tnnuseofirsre
“onas a majortraumaOaet
andkst@usaschc
prinwytcach inghospitalforUTSo
r western.
w
--u-l
.—.
~ &J@f#~”
-...—..———
——-----
- .—
._—
I
—..
——_.
——-—____
4%tw#lilip ‘1–
‘ NeWIJJg-Te3~–”---———--—..--._.———
‘“----–-”
——.
-----
Contact: Susan K. Wilson
Work: (214) 590-8054
April 8, 1997
For immediate Release
—
Mwa!@
-----
___
._
.. . . ____ ___
_. --,.._ _..
. .. . .. . . ____
New drug tested on critically injured trauma patients
DALLAS - Parkland Health & Hospital System’sTrauma Department is one of approximately 35 sites
testing a new drug that may help save the lives of some of the most critically injured trauma patients.
Approximately40 percent of all such patients die as a result of shock due to blood loss, despite the best
medical care available.
The new drug is a blood producl made from expired human red blood cells suspended in a solution. It is
being tested on the most severe!y injured patients at major trauma centers across the country to prevent
the harmful effects of severe blood loss in trauma patients. The blood product is manufactured by Bax[er
HealthCareCorporation’sBlood Substitutes Division.
About 850 patients who are at risk of dying from their injuries will be part of the nationwide trial.
Because of the critical nature of their injuries, few if any of these patients will be capable of giving
informed consent before the drug is administered.
Half of these patients will receive the drug; the other half will receive a saline solution. These patients
also will be given all other standard therapies and procedures normally used to treat shock patients,
including blood, fluids and surgery.
The dmg is a purified hemoglobin solution called Dkspirin Cross-Linked Hemoglobin (DCLHbTM),
which has been authorized for clinical testing by the Food and Drug Administration after four years of
human cIinical trials involving more than 700 patients, including 139 shock and trauma patients.
DCLHbm wiil be administered only to the most severely injured trauma patients to help stabilize shock
and improve patient outcome, according to Dr. David Provo~ chief clinkxd investigator for the drug at
Parkland and assistant professor of surgery at The University of Texas Southwestern Medical Center.
The solution is made from outdated or expired human red blood cells - blood supp~iesthat would
otherwise be removed from blood banks and destroyed. instead, in a new process developed by Baxter,
the blood is treated to remove the hemoglobin, the oxygen-carrying component of the blood, from the
blood AIs. Then it is pasteurii. It does not need to be cross-matched and can easily be stored in
emergency deptutments for immediate use in the most critical trauma eases. (Since the product is made
from human blood, it would not be suitable in treating patients whose religious beliefs forbid blood
tmnsl%sions.)
The new treatment ean shave fkomfiv; to 45 minutes from the time it takes to obtain blood for
trandhdon. For example, matching the victim’sblood type with blood bank supplies can take as long as
45 minutes.
‘When patients have serious traumatic blood loss, the cells are deprived of the oxygen earned by the
hemoglobin and begin to die,” Provost said. “Their blood pressure drops, their organs begin to die, and
, ____.––
000-000007
finally, the patient dies.”
.n.
The only way to intervene in this process is to immediately replace the blood that carries the oxygen-rich
hemoglobin to the cells.
DCLHbTMcan be given to a patient of any blood type without delay, since it contains only the
hemoglobin from the blood cell, not the antigens found on the surface of the cell. The hemoglobin
carries oxygen, and may improve oxygen delivery to the organs that need it most, help reverse the
destructive effects of shock, and save lives.
Becauseof the critical nature of this type of emergency, the FDA has granted an exception from
informed consent normally required in a new drug study. As soon as possible, however, the patient or
the family will be informed of the study and can decide if they wish to continue participating.
Parkland was chosen as a test site because of its reputation as a major trauma center and its status as the
primary
—-
teaching
—--—
hospital
for UT Southwestern.
.—._— —.. - _..
.
. ..
_. ..__.-._.,.._, . ..
Authorized by:
Dep[. of Corporate Communications - Parkland Health&
Hospital System -520 I Harry Hines
.—. . ... -—-.
5908054
-...——- ..-....-.. ..
—
Blvd.- DallasTX 75235-214
.
—-.—— .-— — —.-.. . _________ _____ ._
/
/
/
/
/
/
/
/
.,
u
K-.
#$??J!,
‘i’
(.4/;
.,
‘-
‘
—
.
.-
?’. .
.
/
1
/
/
;