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

Information source: Ethicon, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiovascular, Neurologic (Spine), and General Surgery

Intervention: Human Thrombin (Drug); Bovine Thrombin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ethicon, Inc.

Summary

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.

Clinical Details

Official title: A Comparative Evaluation of Human Thrombin Versus Bovine Thrombin in Achieving Hemostasis in Patients Undergoing Cardiovascular, Neurologic (Spine) and General Surgery Procedures.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Primary outcome: Success in achieving hemostasis.

Secondary outcome:

Success in achieving hemostasis after application

Estimated intraoperative blood loss

Procedure duration

Time in specialty units

Length of hospital stay

Incidence of adverse events.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Alabama Clinical Therapeutics, Birmingham, Alabama 35235, United States

Northwest NeuroSpecialists, PPLC, Tucson, Arizona 85741, United States

Vacular Surgery Associates, Santa Monica, California 90404, United States

Stanford University Medical Center, Stanford, California 94305, United States

Ochsner Clinic, New Orleans, Louisiana 70121, United States

Union Memorial Hospital, Baltimore, Maryland 21218, United States

Borgess Research Institute, Kalamazoo, Michigan 49048, United States

Washington University School of Medicine, St. Louis, Missouri 63110, United States

University of Nebrask Medical Center, Omaha, Nebraska 68105, United States

Cooper University Hospital, Camden, New Jersey 08103, United States

Lehigh Valley Hospital, Allentown, Pennsylvania 18103, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107, United States

University of Tennessee Medical Center, Knoxville, Tennessee 37920, United States

MD Anderson Cancer Center, Houston, Texas 77030, United States

University of Texas Health Science Center at Houston Medical School, Houston, Texas 77030, United States

Scott and White Hospital, Temple, Texas 76508, United States

Neurospine Center of Wisconsin, Appleton, Wisconsin 54913, United States

Additional Information

Starting date: November 2004
Last updated: August 24, 2007

Page last updated: August 23, 2015

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