Download Document 8881470

Blood Substitutes
Baxte/ Healthcare Corporation
Route 120 & Wilson Road
Round Lake, Illinois 60073-0490
847.270,5300
Fax: 847.270.5306
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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
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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%
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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
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“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
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–——
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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
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NEWS TIPS
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NEWS TIPS
NEWS TIPS
April 14, 199?
FOTImrudiate klooM
Contack Swan K Wilson
work (214) S9Q-&)~
Pap (214) 7864527
New drug ttatd
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rntidiy iqjumd tmltfna
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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*
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105s,dospk the best medd cam available.
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nadonwidetrial.Bcoaue of the c&W natureoftkit rnjtiq few Many of thesepatients
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to tho mostseverelyinjured
traumapaficms
to
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Silook andimyOvO paliult OutcOml UcOdhlg IOIX. David Pmv*
chief
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Univdty of TexasSadmM&m
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suppks m * aslongas45 minutes.
- bloodloathecdls amdepnvedofh
Wwxlpasial@bavcscrip Mlmatlo
Ix@ 10 d%” Frovostsaid.‘Their bloodpsessurc
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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
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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.
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.—.
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-...—..———
——-----
- .—
._—
I
—..
——_.
——-—____
4%tw#lilip ‘1–
‘ NeWIJJg-Te3~–”---———--—..--._.———
‘“----–-”
——.
-----
Contact: Susan K. Wilson
Work: (214) 590-8054
April 8, 1997
For immediate Release
—
Mwa!@
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___
._
.. . . ____ ___
_. --,.._ _..
. .. . .. . . ____
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
.
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