NCT00491608

Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

A Phase 3b, Open-Label, Single-Group Immunogenicity and Safety Study of Topical Recombinant Thrombin (rThrombin) in Surgical Hemostasis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: ZymoGenetics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.

Detailed description

This is a Phase 3b, open-label, single-group, multisite safety and immunogenicity study of recombinant thrombin (rThrombin) in participants who are at least 18 years of age and undergoing spinal or vascular surgery. Eligible participants will receive topical rThrombin during surgery and complete a 1-month follow-up visit.

Conditions

• Spinal Surgery
• Vascular Surgery

Interventions

Type	Name	Description
BIOLOGICAL	rThrombin	1000 U/mL applied directly or in combination with absorbable gelatin sponge or powder

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2007-06-26
• Last updated: 2012-01-13
• Results posted: 2012-01-12

Locations

1 site across 1 country: United States