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

Exclusion Criteria

• •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.