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Sponsors and Collaborators: |
Ethicon, Inc. OMRIX Biopharmaceuticals |
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Information provided by: | Ethicon, Inc. |
ClinicalTrials.gov Identifier: | NCT00196534 |
The purpose of this study is to see if Human Thrombin is as effective as Bovine Thrombin in stopping surgical bleeding within 10 minutes of application.
Condition | Intervention | Phase |
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Cardiovascular, Neurologic (Spine), and General Surgery |
Drug: Human Thrombin Drug: Bovine Thrombin |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparative Evaluation of Human Thrombin Versus Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Cardiovascular, Neurologic (Spine) and General Surgery Procedures. |
Estimated Enrollment: | 304 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | July 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients scheduled for any of the following elective surgical procedures:
Cardiovascular Procedures - aortic surgery such as aneurysmectomy, aneurysmoplasty, aneurysmorrhaphy, aneurysmotomy and bypass procedures involving the aorta; major coronary bypass procedures including primary bypass surgery and re-do procedures. Peripheral vascular procedures to include femoral-popliteal bypass, femoral-femoral bypass, or other peripheral vascular procedures requiring vessel grafting with native or prosthetic grafts including Polytetrafluoroethylene (PTFE) grafts; carotid endarterectomies. The sternum is excluded as a Target Site. Bleeding sites evaluated during these procedures may include soft tissues (e.g.
mammary bed, retroperitoneal fat/connective tissues and adhesions) and needle hole bleeding of prosthetic graft material (Change 6, Amend 1).
Bleeding sites evaluated may include soft tissues (e.g. bowel mesentery, adhesions, lymph node beds, sacral venous plexus, etc.) and parenchymal organ bleeds (cut surface of resected liver, spleen, etc., excluding cut surface of kidney) (Amendment #2, Change 44). Bowel anastomoses sites will not be included (Change 8, Amend
1).
Exclusion Criteria:
United States, Alabama | |
Alabama Clinical Therapeutics | |
Birmingham, Alabama, United States, 35235 | |
United States, Arizona | |
Northwest NeuroSpecialists, PPLC | |
Tucson, Arizona, United States, 85741 | |
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305 | |
Vacular Surgery Associates | |
Santa Monica, California, United States, 90404 | |
United States, Louisiana | |
Ochsner Clinic | |
New Orleans, Louisiana, United States, 70121 | |
United States, Maryland | |
Union Memorial Hospital | |
Baltimore, Maryland, United States, 21218 | |
United States, Michigan | |
Borgess Research Institute | |
Kalamazoo, Michigan, United States, 49048 | |
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
University of Nebrask Medical Center | |
Omaha, Nebraska, United States, 68105 | |
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States, 08103 | |
United States, Pennsylvania | |
Thomas Jefferson University Hospital | |
Philadelphia, Pennsylvania, United States, 19107 | |
Lehigh Valley Hospital | |
Allentown, Pennsylvania, United States, 18103 | |
United States, Tennessee | |
University of Tennessee Medical Center | |
Knoxville, Tennessee, United States, 37920 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Scott and White Hospital | |
Temple, Texas, United States, 76508 | |
University of Texas Health Science Center at Houston Medical School | |
Houston, Texas, United States, 77030 | |
United States, Wisconsin | |
Neurospine Center of Wisconsin | |
Appleton, Wisconsin, United States, 54913 |
Study ID Numbers: | 400-04-005 |
Study First Received: | September 12, 2005 |
Last Updated: | August 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00196534 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Thrombin Hemorrhage Hemostatics |
Thrombin Coagulants Therapeutic Uses |
Hematologic Agents Pharmacologic Actions Hemostatics |