Study of Recombinant Human Thrombin for Bleeding During Surgery

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ZymoGenetics
• Treatments: Gelatin Sponge, Absorbable; Thrombin

Criteria

Inclusion Criteria:

• Subject is undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access

Exclusion Criteria:

• Subject has undergone a therapeutic surgical procedure within 30 days prior to surgery

• Subject has history of heparin-induced thrombocytopenia

• Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors or known sensitivity to other components of the study treatment

• Subject has received blood products within 24 hours prior to surgery