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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00161733
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : April 5, 2017
Sponsor:
Information provided by:
Baxter Healthcare Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy Cardiopulmonary Bypass Sternotomy Drug: Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) Drug: TISSEEL VH fibrin sealant Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : September 2002
Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161733


Locations
Show Show 22 study locations
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
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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
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ClinicalTrials.gov Identifier: NCT00161733    
Other Study ID Numbers: 550003
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by Baxter Healthcare Corporation:
Cardiopulmonary bypass
Median sternotomy
Fibrin sealant
Clot
Cardiac surgery
Additional relevant MeSH terms:
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Fibrin Tissue Adhesive
Hemostatics
Coagulants