A Phase 3, Randomized, Double-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Recombinant Human Thrombin (rhThrombin) and Thrombin-JMI (Bovine Thrombin) in Surgical Hemostasis

Trial Information

A Phase 3, Randomized, Double-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Recombinant Human Thrombin (rhThrombin) and Thrombin-JMI (Bovine Thrombin) in Surgical Hemostasis

This is a Phase 3 multiple site, randomized, double-blind, controlled trial designed to
evaluate the comparative efficacy and safety of rhThrombin and bovine thrombin in patients
undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or
arteriovenous graft formation for hemodialysis access.

After establishing eligibility, subjects will be randomized in a 1:1 ratio to receive
rhThrombin (1000 U/mL) or bovine thrombin (1000 U/mL). During a surgical procedure, study
participants will be treated with blinded study drug (rhThrombin or bovine thrombin) in
combination with an absorbable gelatin sponge at appropriate bleeding evaluation site(s) and
time to hemostasis (TTH) will be assessed for up to 10 minutes. Bleeding appropriate for
TTH evaluation is defined as mild to moderate bleeding, either on its own or remaining after
brisk bleeding has been controlled by standard surgical modalities. Blinded study drug may
also be used at additional appropriate bleeding sites. Study participants will have
follow-up visits at about 2 days and 1 month after surgery. Approximately 400 to 600
patients will participate in the study. The final sample size will be determined based on
blinded interim results.