A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery

This study has been completed.
Sponsor:
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
  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:

    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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 August 18, 2014