Status:
COMPLETED
A Study of Fibrocaps™ in Surgical Bleeding
Lead Sponsor:
Mallinckrodt
Conditions:
Mild or Moderate Surgical Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis. The investigational products were used in part...
Eligibility Criteria
Inclusion
- Has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
- Is undergoing one of the 4 surgical procedures described
- Is at least 18 years old at time of consent
- If female and of child-bearing potential, has negative pregnancy test during screening and is not breast-feeding
- If able to reproduce, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits when engaging in heterosexual intercourse
- Has not received blood transfusion between screening and study treatment
- Has mild to moderate surgical bleeding
- Does not have intra-operative complications
- Has not used a topical hemostat containing thrombin prior to study treatment
- Has an approximate bleeding site surface area of less than or equal to 100 cm\^2
Exclusion
- Has known antibodies or hypersensitivity to thrombin or other coagulation factors
- Has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
- Has known allergy to gelatin sponge
- Is unwilling to receive blood products
- Has liver enzymes appropriate for the study, considering their disease
- Has appropriate level of platelets per liter (PLT/L) during screening
- 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 during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
Key Trial Info
Start Date :
May 21 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
721 Patients enrolled
Trial Details
Trial ID
NCT01527357
Start Date
May 21 2012
End Date
June 1 2013
Last Update
December 18 2019
Active Locations (48)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Cardio-Thoracic Surgeons, PC
Birmingham, Alabama, United States, 35242
3
University of Southern California, Keck School of Medicine
Los Angeles, California, United States, 90033
4
University of Southern California/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033