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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.
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Inclusion criteria
All subjects accepted for this study must be:
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:
Exclusion criteria
Any one or more of the following are cause for exclusion from the study:
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Data sourced from clinicaltrials.gov
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