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

• Status: Completed
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3

Details

• Lead Sponsor: Baxter Healthcare Corporation
• Treatments: Fibrin Tissue Adhesive; Hemostatics

Criteria

Inclusion Criteria:

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.

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.