A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery
This study has been completed.
Sponsor:
Ethicon, Inc.
Collaborator:
OMRIX Biopharmaceuticals
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00196534
First received: September 12, 2005
Last updated: August 24, 2007
Last verified: August 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
---|---|---|
Cardiovascular, Neurologic (Spine), and General Surgery |
Drug: Human Thrombin Drug: Bovine Thrombin |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind |
Official Title: | A Comparative Evaluation of Human Thrombin Versus Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Cardiovascular, Neurologic (Spine) and General Surgery Procedures. |
Resource links provided by NLM:
Further study details as provided by Ethicon, Inc.:
Primary Outcome Measures:
- Success in achieving hemostasis.
Secondary Outcome Measures:
- Success in achieving hemostasis after application
- Estimated intraoperative blood loss
- Procedure duration
- Time in specialty units
- Length of hospital stay
- Incidence of adverse events.
Estimated Enrollment: | 304 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | July 2006 |
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female patients, of any race, 18 years or older.
- 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:
- 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).
- 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).
- 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 with bleeding diathesis, pathologic coagulopathy, systemic disorders, or autoimmune, immunodeficiency diseases or any other disorder that may interfere with hemostasis.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196534
Locations
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 | |
Vacular Surgery Associates | |
Santa Monica, California, United States, 90404 | |
Stanford University Medical Center | |
Stanford, California, United States, 94305 | |
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 | |
Lehigh Valley Hospital | |
Allentown, Pennsylvania, United States, 18103 | |
Thomas Jefferson University Hospital | |
Philadelphia, Pennsylvania, United States, 19107 | |
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 | |
University of Texas Health Science Center at Houston Medical School | |
Houston, Texas, United States, 77030 | |
Scott and White Hospital | |
Temple, Texas, United States, 76508 | |
United States, Wisconsin | |
Neurospine Center of Wisconsin | |
Appleton, Wisconsin, United States, 54913 |
Sponsors and Collaborators
Ethicon, Inc.
OMRIX Biopharmaceuticals
More Information
No publications provided by Ethicon, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided by Ethicon, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00196534 History of Changes |
Other Study ID Numbers: | 400-04-005 |
Study First Received: | September 12, 2005 |
Last Updated: | August 24, 2007 |
Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
Thrombin Hemostatics Coagulants |
Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 16, 2012