Status:
COMPLETED
Study of Recombinant Human Thrombin for Bleeding During Surgery
Lead Sponsor:
ZymoGenetics
Conditions:
Surgical Hemostasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
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 sur...
Eligibility Criteria
Inclusion
- Subject is undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT00245336
Start Date
October 1 2005
End Date
July 1 2006
Last Update
March 9 2009
Active Locations (29)
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1
Cardio Thoracic Surgeons, P.C.
Birmingham, Alabama, United States, 35213
2
Cardio Thoracic Surgeons, P.C., Medical Center East / Baptist Montclair
Birmingham, Alabama, United States, 35235
3
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
4
Methodist Hospital
Arcadia, California, United States, 91007