Phase 3 Study of Fibrocaps™ in Surgical Bleeding
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2013 |
Start Date: | May 2012 |
End Date: | May 2013 |
Contact: | Paul Frohna, MD, PhD |
Email: | p.frohna@profibrix.com |
Phone: | 206-499-6462 |
A Phase 3, Randomized, Single-blind, Controlled Trial of Topical Fibrocaps™ in Intraoperative Surgical Hemostasis
The primary objective of the study is to demonstrate the superiority of Fibrocaps plus
gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects
with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue
surgery.
This is a Phase 3, international, multi-center, randomized, single-blind, controlled trial
that will be conducted at clinical trial sites in the EU and US.
Inclusion Criteria:
1. Subject has signed an institutional review board/independent ethics committee
(IRB/IEC)-approved informed consent document
2. Subject is undergoing one of the 4 surgical procedures described
3. Subject age is >18 years at time of consent
4. If female and of child-bearing potential, subject has negative pregnancy test during
screening and is not breast-feeding
5. 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 follow-up study visits
6. Subject has not received blood transfusion between screening and study treatment
7. Presence of mild to moderate surgical bleeding
8. Absence of intra-operative complications
9. No intra-operative use of a topical hemostat containing thrombin prior to study
treatment
10. Approximate bleeding site surface area of less than or equal to 100 cm2
Exclusion Criteria:
1. Subject has known antibodies or hypersensitivity to thrombin or other coagulation
factors
2. Subject has history of heparin-induced thrombocytopenia (only for vascular subjects
where heparin use is required)
3. Subject has known allergy to porcine gelatin
4. Subject is unwilling to receive blood products
5. Has any clinically-significant coagulation disorder that may interfere with the
assessment of efficacy or pose a safety risk to the subject according to the
Investigator, or baseline abnormalities of INR > 2.5 or aPTT > 100 seconds during
screening that are not explained by current drug treatment (e.g., warfarin, heparin)
6. Aspartate Aminotransferase (ASAT/AST ) or 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 metastases where there is no upper
limit for these analytes due to the nature of their disease
7. Platelets < 100 x109 PLT/L during screening
We found this trial at
28
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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801 N Rutledge St
Springfield, Illinois 62702
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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