A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery
NCT ID: NCT00196534
Last Updated: 2007-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
304 participants
INTERVENTIONAL
2004-11-30
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Interventions
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Human Thrombin
Bovine Thrombin
Eligibility Criteria
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Inclusion Criteria
* Patients who have at least one bleeding site within the operative field that is mild (oozing or capillary bleeding) to moderate (gradual or steady bleeding) in intensity and which cannot be managed by surgical modalities because they are ineffective or impractical (Change 15, Amend 1).
* Patients scheduled for any of the following elective surgical procedures:
1. 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).
2. Neurosurgical (spine) Procedures- primary lumbar laminectomy and laminectomy with fusion (fusion must be done after the time to hemostasis assessment). Re-do laminectomy, removal of tumors/lesions during laminectomy, cervical, or thoracic laminectomy procedures will be excluded. Bleeding sites evaluated may include periosteum, bone marrow, venous plexus (Change 7, Amend 1).
3. General Surgery or Post-Traumatic (hemodynamically stable and non-coagulopathic) procedures: bowel and colon resections, retroperitoneal dissections/resections, and procedures involving the resection of any solid abdominal organ such as a splenectomy, liver resection, nephrectomy, splenorrhaphy, and pancreatectomy. 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).
* Patient, or the patient's legally authorized representative, must provide legally effective informed consent prior to any participation in the study. (Amendment #2, Change 41)
Exclusion Criteria
* Patients who have had a pre-operative laboratory finding that was considered clinically significant (as determined by the Investigator) for CBC (HCT, Hgb, white blood cell differential, platelet count, and Red Blood Cell (RBC) indices (MCH, MCV, MCHC)), prothrombin time (PT), or activated partial thromboplastin time (aPTT).
* Patients who have used anticoagulant, antiplatelet or nonsteroidal anti-inflammatory analgesic (NSAID) within 5 days prior to surgery (the use of ASA or aprotinin is permitted).
* Patients with known antibodies to bovine thrombin preparations.
* Patients receiving an organ transplant (liver, heart, kidney, etc.).
* Patients who are morbidly obese (Body Mass Index \> 35).
* Patients with acute or chronic liver failure (Amendment #2, Change 42).
* Patients with all severe (brisk or forceful) bleeding site(s).
* Patients with an ongoing infection at the operative site.
* Patients who are known alcohol and/or drug abusers.
* Female patients who are pregnant or nursing.
* Patients who have uncontrolled diabetes mellitus (blood glucose levels \>400 mg/dl) as determined by the Investigator based on medical history (Change 14, Admin. Change 2).
* Patients who have participated in another investigational drug or device research within 30 days of enrollment.
18 Years
ALL
No
Sponsors
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OMRIX Biopharmaceuticals
INDUSTRY
Ethicon, Inc.
INDUSTRY
Locations
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Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Northwest NeuroSpecialists, PPLC
Tucson, Arizona, United States
Vacular Surgery Associates
Santa Monica, California, United States
Stanford University Medical Center
Stanford, California, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Borgess Research Institute
Kalamazoo, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebrask Medical Center
Omaha, Nebraska, United States
Cooper University Hospital
Camden, New Jersey, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Texas Health Science Center at Houston Medical School
Houston, Texas, United States
Scott and White Hospital
Temple, Texas, United States
Neurospine Center of Wisconsin
Appleton, Wisconsin, United States
Countries
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References
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Doria C, Fischer CP, Wood CG, Li PM, Marra S, Hart J. Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery. Curr Med Res Opin. 2008 Mar;24(3):785-94. doi: 10.1185/030079908X273426. Epub 2008 Jan 31.
Other Identifiers
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400-04-005
Identifier Type: -
Identifier Source: org_study_id