Study of Recombinant Human Thrombin for Bleeding During Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Surgical Hemostasis

Intervention / Treatment
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* Biological: rThrombin
* Drug: bovine thrombin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>rThrombin | Biological: rThrombin<br>* 1000 U/mL applied topically in combination with absorbable gelatin sponge<br>|
| Active Comparator: 2<br>bThrombin | Drug: bovine thrombin<br>* 1000 U/mL applied topically in combination with absorbable gelatin sponge<br>* Other names: Thrombin-JMI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemostasis, surgery, hemostatics, randomized controlled trial, phase 3