Study of Recombinant Human Thrombin for Bleeding During Surgery
- Conditions
- Surgical Hemostasis
- Interventions
- Biological: rThrombin
- Registration Number
- NCT00245336
- Lead Sponsor
- ZymoGenetics
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 401
- Subject is undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 rThrombin rThrombin 2 bovine thrombin bThrombin
- Primary Outcome Measures
Name Time Method Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes 10 minutes
- Secondary Outcome Measures
Name Time Method Incidence and severity of adverse events Up to 29 days Incidence and grade of clinical laboratory abnormalities Up to 29 days Incidence of anti-product antibodies Up to 29 days
Trial Locations
- Locations (28)
Cardio Thoracic Surgeons, P.C.
🇺🇸Birmingham, Alabama, United States
Cardio Thoracic Surgeons, P.C., Medical Center East / Baptist Montclair
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Methodist Hospital
🇺🇸Arcadia, California, United States
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States
University of Southern California, Keck School of Medicine
🇺🇸Los Angeles, California, United States
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
Baptist Clinical Research
🇺🇸Pensacola, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
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