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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary Bypass; Sternotomy; Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy
• Intervention / Treatment: Drug: Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D); Drug: TISSEEL VH fibrin sealant

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Health Research Institute
  • California
    • Orange, California, United States, 92868-3298
      • UCI Medical Center
  • Florida
    • Gainesville, Florida, United States, 32610-0286
      • Shands Hospital at the University of Florida
    • Melbourne, Florida, United States, 32901
      • Brevard Cardio Surgeons/Health First Heart Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Peachtree Cardiovascular
    • Savannah, Georgia, United States, 31405
      • St. Joseph's/Candler Health System, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0293
      • University of Kentucky Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5501
      • Beth Israel Deaconess Medical Center
    • Springfield, Massachusetts, United States, 01199
      • Cardiac Surgery Service, Baystate Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0344
      • University of Michigan Hospital
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Washington University Medical Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • UMDNJ - Robert Wood Johnson Medical School
  • New York
    • New York, New York, United States, 10021
      • Lenox Hill Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Linder Clinical Trial Center
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97213
      • The Oregon Clinic
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Tacoma, Washington, United States, 98405
      • Franciscan Health System Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Jeffrey Milliken, MD, UCI Medical Center, Orange, CA; Principal Investigator: John Rousou, MD, Baystate Medical Center, Springfield, MA; Principal Investigator: Charles Klodell, MD, Shads Hospital at the University of Florida, Gainesville, FL; Principal Investigator: Russell Vester, MD, The Linder Clinical Trial Center, Cincinnati, OH; Principal Investigator: Nicholas Smedira, MD, The Cleveland Clinic, Cleveland, OH; Principal Investigator: Steven Bolling, MD, University of Michigan Hospital, Ann Arbor, MI; Principal Investigator: Sidney Levitsky, MD, Beth Israel Deaconess Medical Center, Boston MA; Principal Investigator: James Lowe, MD, Duke University Medical Center, Durham, NC; Principal Investigator: E. Charles Douville, MD, The Oregon Clinic, Portland, OR; Principal Investigator: Robert Jones, MD, St. Joseph´s/Candler Health System, Inc., Savannah, GA; Principal Investigator: Robert Mentzer, MD, University of Kentucky Medical Center, Lexington, KY; Principal Investigator: Steven Macheers, MD, Peachtree Cardiovascular, Atlanta, GA; Principal Investigator: Robert Hebeler, MD, Baylor University Medical Center, Dallas, TX; Principal Investigator: Michael Greene, MD, Brevard Cardio Surgeons/Health First Heart Institute, Melbourne, FL; Principal Investigator: Valluvan Jeevanandam, MD, University of Chicago Medical Center, Chicago, IL; Principal Investigator: John Luber, MD, Franciscan Health System Research Center, Tacoma, WA; Principal Investigator: Irving Kron, MD, University of Vigrinia Health System, Charlottesville, VA; Principal Investigator: Michael McGrath, MD, Sentara Norfolk General Hospital, Norfolk, VA; Principal Investigator: Marc Moon, MD, Washington University Medical Center, St. Louis, MO; Principal Investigator: Steven Marra, MD, UMDNJ - Robert Wood Johnson Medical School, Camden, NJ; Principal Investigator: Ramachandra Reddy, MD, Lenox Hill Hospital, New York, NY; Principal Investigator: Pierre Tibi, MD, Banner health Research Institute, Phoenix, AZ

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Study Completion: November 1, 2004

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 10, 2005
• First Posted (Estimate): September 13, 2005

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Cardiac surgery; Cardiopulmonary bypass; Median sternotomy; Clot; Fibrin sealant
• Additional Relevant MeSH Terms: Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: 550003