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

J. Lowe, J. Luber, S. Levitsky, E. Hantak, J. Montgomery, N. Schiestl, Neil Schofield, S. Marra, J. Milliken, C. Douville, J. Rousou, R. Jones, I. Kron, C. Klodell, R. Mentzer, S. Szentpetery, R. Vester, S. Macheers, M. R. Moon, M. SmediraR. Hebeler, S. Boiling, M. Greene, V. Jeevanandam, P. Tibi

Research output: Contribution to journalArticle

27 Scopus citations

Abstract

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 assesed 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.

Original languageEnglish (US)
Pages (from-to)323-331
Number of pages9
JournalJournal of Cardiovascular Surgery
Volume48
Issue number3
StatePublished - Jun 2007
Externally publishedYes

Keywords

  • Cardiac surgery
  • Fibrin tissue adhesive
  • Hemostasis

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

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    Lowe, J., Luber, J., Levitsky, S., Hantak, E., Montgomery, J., Schiestl, N., Schofield, N., Marra, S., Milliken, J., Douville, C., Rousou, J., Jones, R., Kron, I., Klodell, C., Mentzer, R., Szentpetery, S., Vester, R., Macheers, S., Moon, M. R., ... Tibi, P. (2007). 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. Journal of Cardiovascular Surgery, 48(3), 323-331.