Clinical trial NCT00161733: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy
Cardiopulmonary Bypass
Sternotomy
Keywords: Cardiopulmonary bypass
Median sternotomy
Fibrin sealant
Clot
Cardiac surgery
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Health Research Institute
state: Arizona
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
city: Melbourne
country: United States
facility: Brevard Cardio Surgeons/Health First Heart Institute
state: Florida
city: Atlanta
country: United States
facility: Peachtree Cardiovascular
state: Georgia
city: Savannah
country: United States
facility: St. Joseph's/Candler Health System, Inc.
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Cardiac Surgery Service, Baystate Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
city: St. Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Camden
country: United States
facility: UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Linder Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Tacoma
country: United States
facility: Franciscan Health System Research Center
state: Washington
Study officials:
affiliation: UCI Medical Center, Orange, CA
name: Jeffrey Milliken, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baystate Medical Center, Springfield, MA
name: John Rousou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shads Hospital at the University of Florida, Gainesville, FL
name: Charles Klodell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Linder Clinical Trial Center, Cincinnati, OH
name: Russell Vester, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic, Cleveland, OH
name: Nicholas Smedira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan Hospital, Ann Arbor, MI
name: Steven Bolling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center, Boston MA
name: Sidney Levitsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Medical Center, Durham, NC
name: James Lowe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Oregon Clinic, Portland, OR
name: E. Charles Douville, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph´s/Candler Health System, Inc., Savannah, GA
name: Robert Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky Medical Center, Lexington, KY
name: Robert Mentzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peachtree Cardiovascular, Atlanta, GA
name: Steven Macheers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor University Medical Center, Dallas, TX
name: Robert Hebeler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brevard Cardio Surgeons/Health First Heart Institute, Melbourne, FL
name: Michael Greene, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago Medical Center, Chicago, IL
name: Valluvan Jeevanandam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Franciscan Health System Research Center, Tacoma, WA
name: John Luber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vigrinia Health System, Charlottesville, VA
name: Irving Kron, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sentara Norfolk General Hospital, Norfolk, VA
name: Michael McGrath, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University Medical Center, St. Louis, MO
name: Marc Moon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMDNJ - Robert Wood Johnson Medical School, Camden, NJ
name: Steven Marra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lenox Hill Hospital, New York, NY
name: Ramachandra Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Banner health Research Institute, Phoenix, AZ
name: Pierre Tibi, MD
role: PRINCIPAL_INVESTIGATOR
References: