A Study of Fibrocaps™ in Surgical Bleeding

Inclusion criteria

• 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 criteria

• 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)