Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S… (NCT00161733) | Clinical Trial Compass
CompletedPhase 3
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
United StatesStarted 2002-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
* Hi…