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Sponsored by: |
ZymoGenetics |
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Information provided by: | ZymoGenetics |
ClinicalTrials.gov Identifier: | NCT00245336 |
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.
Condition | Intervention | Phase |
---|---|---|
Surgical Hemostasis |
Biological: rThrombin Drug: bovine thrombin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 401 |
Study Start Date: | October 2005 |
Study Completion Date: | July 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
rThrombin
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Biological: rThrombin
1000 U/mL applied topically in combination with absorbable gelatin sponge
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2: Active Comparator
bThrombin
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Drug: bovine thrombin
1000 U/mL applied topically in combination with absorbable gelatin sponge
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Thomas C Reynolds, MD, PhD | ZymoGenetics |
Principal Investigator: | William Chapman, MD | Washington University School of Medicine |
Principal Investigator: | Kenneth Renkens, MD | Indiana Spine Group |
Principal Investigator: | Fred Weaver, MD | University of Southern California |
Responsible Party: | ZymoGenetics, Inc. ( Allan Alexander, MD ) |
Study ID Numbers: | 499E01 |
Study First Received: | October 25, 2005 |
Last Updated: | March 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00245336 History of Changes |
Health Authority: | United States: Food and Drug Administration |
hemostasis surgery hemostatics randomized controlled trial phase 3 |
Thrombin Gelatin Sponge, Absorbable Hemorrhage Hemostatics |
Thrombin Coagulants Therapeutic Uses |
Hematologic Agents Pharmacologic Actions Hemostatics |