Safety and Efficacy Study of Raplixa™ (Fibrin Sealant [Human]) to Treat Surgical Bleeding in Children



Status:Active, not recruiting
Healthy:No
Age Range:Any - 17
Updated:12/10/2017
Start Date:December 2014
End Date:September 2018

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A Phase 2, Randomized, Single-Blind, Controlled Trial of Topical Raplixa™ (Fibrin Sealant [Human]) in Intraoperative Surgical Hemostasis in a Pediatric Population

The purpose of the study is to show that Raplixa plus gelatin sponge is better than gelatin
sponge alone in stopping mild to moderate bleeding in children having surgery


The study will enroll subjects undergoing one of the following surgical procedures:

- Vascular Surgery

- Hepatic surgery

- Soft tissue surgery

- Renal surgery

- Spinal surgery

Inclusion Criteria (pre-surgery):

1. Age is ≥36 weeks gestational age at birth (for infants) through <18 years of age at
time of treatment

2. Subject's legal representative (parent or guardian) has signed an institutional review
board (IRB)-approved informed consent document

3. If a subject is ≥ 7 years old, or appropriate age as defined by local regulations, the
subject may be required to have signed an IRB-approved assent document

4. Subject is scheduled to undergo one of the surgical procedures described above

5. If female and of child-bearing potential, subject has negative pregnancy test on the
day of surgery (baseline)

6. If subject is a sexually active male or a sexually active female of child-bearing
potential, subject agrees to use a medically accepted form of contraception from the
time of consent to completion of all of the follow-up study visits.

Inclusion Criteria (during surgery):

7. Presence of mild or moderate bleeding/oozing

8. Target Bleeding Sites surface area of ≤100 cm2

9. Has not received any whole blood, fresh frozen plasma (FFP), cryoprecipitate, or
platelets within 24 hours prior to study drug. Packed red blood cell (PRBC)
transfusions are allowed

10. No complication during surgery other than bleeding which, in the opinion of the
Investigator, may interfere with the assessment of efficacy or safety

Exclusion Criteria:

1. Gestational age of <36 weeks at birth (for infants less than 6 months of age)

2. Any clinically-significant congenital coagulation disorder (e.g., hemophilia A or B)
that may interfere with the assessment of efficacy or pose a safety risk to the
subject according to the Investigator

3. Baseline abnormalities of international normalized ratio (INR) > 2.5 or activated
partial thromboplastin time (aPTT) > 100 seconds during screening that are not
explained by current drug treatment (e.g., warfarin, heparin) or chronic disease state
necessitating surgery (e.g., end stage liver disease).

4. Aspartate Aminotransferase (ASAT/AST) and Alanine aminotransferase (ALAT/ALT) > 3 x
upper limit normal range during screening, except for subjects undergoing liver
resection surgery or with a diagnosis of liver disease where there is no upper limit
for these analytes due to nature of their disease

5. Subject is unwilling to receive blood products or products derived from human blood

6. Platelets < 100 x10ᴧ9 PLT/L during screening unless due to chronic disease state,
e.g., liver disease/failure, necessitating surgery

7. Subject has known antibodies or hypersensitivity to Raplixa or any of it's components,
other thrombin preparations or coagulation factors

8. Known allergy to porcine gelatin

9. Medical, social, or psychosocial factors that, in the opinion of the Investigator,
could impact subject safety or compliance with study procedures

10. Subject is; 1) currently participating in another clinical study or 2) has
participated in another clinical study within 30 days of screening or 3) plans to
participate in a clinical study prior to completion of the 30-day follow-up period
We found this trial at
13
sites
Philadelphia, Pennsylvania 19134
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, GA
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, IL
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Dallas, TX
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Jacksonville, Florida 32207
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Phoenix, AZ
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Roanoke, Virginia
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Sacramento, California 95817
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Saint Louis, Missouri 63110
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Saint Louis, MO
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4800 Sand Point Way Northeast
Seattle, Washington 98105
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Seattle, WA
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Wayne, Pennsylvania 19087
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Wayne, PA
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Winston-Salem, North Carolina 26157
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Winston-Salem, NC
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