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.

Published

Journal Article

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.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.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.TISSEEL VH S/D is safe and effective for use as an adjunct to hemostasis in patients undergoing cardiac surgery.

Full Text

Duke Authors

Cited Authors

  • Lowe, J; Luber, J; Levitsky, S; Hantak, E; Montgomery, J; Schiestl, N; Schofield, N; Marra, S; TISSEEL Clinical Study Group,

Published Date

  • June 2007

Published In

Volume / Issue

  • 48 / 3

Start / End Page

  • 323 - 331

PubMed ID

  • 17505437

Pubmed Central ID

  • 17505437

Electronic International Standard Serial Number (EISSN)

  • 1827-191X

International Standard Serial Number (ISSN)

  • 0021-9509

Language

  • eng