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, 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

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.

Keywords: bleeding scale; collagen; hemostat; hemostatic agent; hemostatic combination powder; thrombin.

Conflict of interest statement

Ardehali is a member of the Board of Directors of Biom'up SA. Bruckner and Gillen are paid consultants of Biom'up SA. Hoffman, R. Spotnitz, Cavoores, Schorn, Manson, and W. Spotnitz are employees of Biom'up SA.

© 2019 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals, Inc.

Figures

Figure 1
Figure 1
The proportion of subjects in each treatment group achieving hemostasis at 3 and 5 minutes

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