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


Phase 3
18 Years
N/A
Not Enrolling
Both
Cardiovascular, Neurologic (Spine), and General Surgery

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Success in achieving hemostasis.

Authority:

United States: Food and Drug Administration

Study ID:

400-04-005

NCT ID:

NCT00196534

Start Date:

November 2004

Completion Date:

July 2006

Related Keywords:

  • Cardiovascular, Neurologic (Spine), and General Surgery

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Stanford University Medical CenterStanford, California  94305-5408
Washington University School of MedicineSaint Louis, Missouri  63110
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Cooper University HospitalCamden, New Jersey  08103
Ochsner ClinicNew Orleans, Louisiana  70121
Union Memorial HospitalBaltimore, Maryland  21218
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Alabama Clinical TherapeuticsBirmingham, Alabama  35235
Northwest NeuroSpecialists, PPLCTucson, Arizona  85741
Vacular Surgery AssociatesSanta Monica, California  90404
Borgess Research InstituteKalamazoo, Michigan  49048
University of Nebrask Medical CenterOmaha, Nebraska  68105
University of Tennessee Medical CenterKnoxville, Tennessee  37920
University of Texas Health Science Center at Houston Medical SchoolHouston, Texas  77030
Scott and White HospitalTemple, Texas  76508
Neurospine Center of WisconsinAppleton, Wisconsin  54913