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document
Evaluation of the topical hemostatic efficacy and safety of TISSEEL VH S/D fibrin sealant compared with currently licensed TISSEEL VH in patients undergoing cardiac surgery : a phase 3 , randomized , double-blind clinical study . AIM TISSEEL VH is the only commercially available fibrin sealant indicated as an adjunct to conventional methods of hemostasis during cardiac surgery . A next generation fibrin sealant ( TISSEEL VH S/D ) has been developed in frozen , ready-to-use form with an added virus inactivation step ( solvent/detergent [ S/D ] treatment ) to provide added safety and convenience to the currently licensed product . This study was performed to compare efficacy and safety of the two products . METHODS Phase 3 , prospective , randomized , double-blind , multicenter study to compare TISSEEL VH S/D to TISSEEL VH during cardiac surgery . The primary efficacy endpoint was the proportion of patients who achieved hemostasis at the primary treatment site within 5 min , and maintained hemostasis until surgical closure . RESULTS The proportion of patients who achieved hemostasis at the primary treatment site within 5 min , and maintained hemostasis until surgical closure was 88.2 % for TISSEEL VH S/D and 89.6 % for TISSEEL VH in the intent-to-treat population . The difference in proportions , TISSEEL VH S/D minus TISSEEL VH , was 1.4 % with a standard error of 3.70 % . The lower 97.5 % confidence bound of this difference was 8.6 % , which is above the predefined noninferiority margin of 15 % . Therefore , TISSEEL VH S/D is at least as efficacious as TISSEEL VH . The safety profile of TISSEEL VH S/D was very similar to that of currently licensed TISSEEL VH as assessed by the safety endpoints . CONCLUSION TISSEEL VH S/D is safe and effective for use as an adjunct to hemostasis in patients undergoing cardiac surgery .
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Intervention_Pharmacological
TISSEEL VH S/D fibrin sealant
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Intervention_Pharmacological
currently licensed TISSEEL VH
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Intervention_Pharmacological
fibrin sealant ( TISSEEL VH S/D )
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Intervention_Pharmacological
TISSEEL VH S/D to TISSEEL VH
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Outcome_Other
efficacy and safety
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Outcome_Other
efficacy and safety
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Outcome_Physical
proportion of patients who achieved hemostasis
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Outcome_Physical
proportion of patients who achieved hemostasis
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Outcome_Physical
maintained hemostasis
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Outcome_Other
safe
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Outcome_Other
effective
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Participant_Condition
patients undergoing cardiac surgery .