Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery

Completed · Phase 3

Conditions studied: Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy, Cardiopulmonary Bypass, Sternotomy

In brief

The objective of this study is to demonstrate equivalent hemostatic efficacy and safety between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery requiring cardiopulmonary bypass. If bleeding is still present after conventional surgical methods to achieve hemostasis have been applied FS VH S/D or Tisseel VH are applied. Achievement of hemostasis within 5 minutes is compared between the study groups.

Key facts

Study ID: NCT00161733
Run by: Baxter Healthcare Corporation
Starts: 2002-09-01
Expected to finish: 2004-11-01
Last updated by the study team: 2017-04-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All subjects accepted for this study must be:
Informed of the nature of the study and have provided written informed consent
>= 18 years of age
Scheduled to undergo cardiac surgery requiring CPB and median sternotomy
Able and willing to comply with the procedures required by the protocol.
Additional Intraoperative Eligibility Criteria (in addition to the above):
Subjects must satisfy the following intraoperative criteria in order to be eligible for treatment with either investigational product:
Subjects must complete all screening/preoperative evaluations (see study protocol)
Subjects must present, after cessation of cardiopulmonary bypass and heparin reversal by protamine sulfate, with a minimum of one intraoperative bleeding site which cannot be controlled by conventional surgical techniques (i.e., suture, ligature, cautery, clips, and clamps) alone and which has not been previously treated with any topical hemostatic agent
Subjects must not have received any commercial or blood bank-derived fibrin sealant prior to application of investigational product.

You may not qualify if…

Any one or more of the following are cause for exclusion from the study:
Subject is scheduled to undergo a cardiac surgical procedure which does not require CPB and median sternotomy (e.g., thoracotomy, minimally invasive direct coronary artery bypass, etc.)
Subject has undergone a sternotomy within 36 hours prior to being randomized under this protocol
History of any hereditary or acquired bleeding disorders. Subjects concurrently treated with prophylactic antithrombotic therapy (i.e., aspirin, heparin, Warfarin, etc.) are eligible
Either of the following: International Normalized Ratio (INR) >1.35, activated or partial thromboplastin time (aPTT) greater than 35 seconds in subjects who are not on antithrombotic therapy (i.e., aspirin, heparin, Warfarin, etc.)
Fibrinogen level less than 150mg/dL
Platelet count less than 100,000/mm3
Active hepatic disease (persistent alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than 2.5X the upper limit of normal)
Subject was previously randomized under this protocol
Pregnancy or lactation
Known sensitivity to aprotinin or bovine protein
Subject is currently participating in another clinical study and has received an investigational product or device within 30 days prior to study entry
Treatment with thrombolytic agents (e.g. tissue plasminogen activator [tPA], Streptase® [streptokinase], Activase® [alteplase], Retavase® [reteplase],) Integrilin® (eptifibatide), Aggrastat® (tirofiban), Plavix® (clopidogrel), ReoPro® (abciximab), or Ticlid® (ticlopidine), Pletal® (cilostazol) < 24 hours prior to treatment with investigative product
Subject is scheduled for heart transplantation
Subject is scheduled for left ventricular assist device insertion or removal
Subject is scheduled to undergo any surgical procedure other than the cardiac surgery for which the subject is being treated under this protocol within 14 days prior to treatment. Surgeries in the pericardium associated with the cardiac surgery and not specifically excluded above are permitted.
Subject has an anticipated life expectancy of <=6 months.

Where it is running

Banner Health Research Institute — Phoenix, Arizona, United States
UCI Medical Center — Orange, California, United States
Shands Hospital at the University of Florida — Gainesville, Florida, United States
Brevard Cardio Surgeons/Health First Heart Institute — Melbourne, Florida, United States
Peachtree Cardiovascular — Atlanta, Georgia, United States
St. Joseph's/Candler Health System, Inc. — Savannah, Georgia, United States
University of Chicago Medical Center — Chicago, Illinois, United States
University of Kentucky Medical Center — Lexington, Kentucky, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Cardiac Surgery Service, Baystate Medical Center — Springfield, Massachusetts, United States
University of Michigan Hospital — Ann Arbor, Michigan, United States
Washington University Medical Center — St Louis, Missouri, United States
UMDNJ - Robert Wood Johnson Medical School — Camden, New Jersey, United States
Lenox Hill Hospital — New York, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
The Linder Clinical Trial Center — Cincinnati, Ohio, United States
The Cleveland Clinic — Cleveland, Ohio, United States
The Oregon Clinic — Portland, Oregon, United States
Baylor University Medical Center — Dallas, Texas, United States
University of Virginia Health System — Charlottesville, Virginia, United States
Sentara Norfolk General Hospital — Norfolk, Virginia, United States
Franciscan Health System Research Center — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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