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

Cardiopulmonary Bypass Clinical Trial

Official title:

Evaluation of the Topical Hemostatic Efficacy and Safety of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161733
• Other study ID #: 550003
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: April 4, 2017
• Start date: September 2002
• Est. completion date: November 2004

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2004
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy
• Cardiopulmonary Bypass
• Sternotomy

Intervention

Drug:
• Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D)

• TISSEEL VH fibrin sealant

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States,