A Study of Fibrocaps™ in Surgical Bleeding

Launched by MALLINCKRODT · Feb 6, 2012

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Has signed an institutional review board/independent ethics committee (IRB/IEC)-approved informed consent document
• • 2. Is undergoing one of the 4 surgical procedures described
• • 3. Is at least 18 years old at time of consent
• • 4. If female and of child-bearing potential, has negative pregnancy test during screening and is not breast-feeding
• • 5. 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
• • 6. Has not received blood transfusion between screening and study treatment
• • 7. Has mild to moderate surgical bleeding
• • 8. Does not have intra-operative complications
• • 9. Has not used a topical hemostat containing thrombin prior to study treatment
• • 10. Has an approximate bleeding site surface area of less than or equal to 100 cm\^2
• Exclusion Criteria:
• • 1. Has known antibodies or hypersensitivity to thrombin or other coagulation factors
• • 2. Has history of heparin-induced thrombocytopenia (only for vascular subjects where heparin use is required)
• • 3. Has known allergy to gelatin sponge
• • 4. Is unwilling to receive blood products
• • 5. Has liver enzymes appropriate for the study, considering their disease
• • 6. Has appropriate level of platelets per liter (PLT/L) during screening
• • 7. 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)