Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations

Nicholas C. Dang, Abbas Ardehali, Brian A. Bruckner, Patrick E. Parrino, Daniel L. Gillen, Rachel W. Hoffman, Russell Spotnitz, Stephanie Cavoores, Ian J. Shorn, Roberto J. Manson, William D. Spotnitz

Research output: Contribution to journalArticle

1 Scopus citations

Abstract

Aim: This trial compared the hemostatic performance of a novel combination powder (CP) to a control hemostatic matrix (HM) in cardiothoracic operations. Methods: Patients meeting eligibility criteria were enrolled after providing informed consent. Subjects were randomized intraoperatively to receive CP (HEMOBLAST Bellows; Biom'up, France) or HM (FLOSEAL Hemostatic Matrix; Baxter Healthcare Corporation, Hayward, CA). Bleeding was assessed using a clinically validated, quantitative bleeding severity scale. The primary endpoint was total time to hemostasis (TTTH), from the start of device preparation, as an indicator of when a surgeon asks for a surgical hemostat until hemostasis was achieved. TTTH at 3 minutes was utilized for the primary analysis, while TTTH at 5 minutes was considered as a secondary endpoint. Results: A total of 105 subjects were enrolled across four institutions. The primary efficacy endpoint for the superiority of CP relative to HM for success at achieving hemostasis within 3 minutes was met, with 64.2% of the CP group achieving hemostasis compared with 9.6% of the HM group, a difference of 54.54% (37.4%-71.6%; P <.001 for superiority). The secondary efficacy endpoint was also met, with 92.5% of the CP group achieving hemostasis at 5 minutes versus 44.2% in the HM group, a difference of 48.2% (31.1%-65.4%; P <.001 for noninferiority). There were no device-related adverse events. Conclusions: In this multicenter, randomized, controlled trial, comparison of CP to HM revealed CP superiority and noninferiority for TTTH at 3 and 5 minutes, respectively.

Original languageEnglish (US)
Pages (from-to)313-319
Number of pages7
JournalJournal of cardiac surgery
Volume35
Issue number2
DOIs
StatePublished - Feb 1 2020

Keywords

  • bleeding scale
  • collagen
  • hemostat
  • hemostatic agent
  • hemostatic combination powder
  • thrombin

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Fingerprint Dive into the research topics of 'Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations'. Together they form a unique fingerprint.

Cite this