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

Autor: Dang NC; Department of Surgery, Kaiser Moanalua Medical Center, Honolulu, Hawaii., Ardehali A; Department of Surgery, University of California at Los Angeles, Los Angeles, California., Bruckner BA; Methodist DeBakey Heart and Vascular Center, Houston Methodist Hospital, Houston, Texas., Parrino PE; Thoracic and Cardiovascular Surgery Section, Ochsner Medical Center, New Orleans, Louisiana., Gillen DL; Department of Statistics, University of California, Irvine, California., Hoffman RW; Biom'up SA, Lyon, France., Spotnitz R; Biom'up SA, Lyon, France., Cavoores S; Biom'up SA, Lyon, France., Shorn IJ; Biom'up SA, Lyon, France., Manson RJ; Biom'up SA, Lyon, France.; Department of Surgery, Duke University, Durham, North Carolina.; Department of Mechanical Engineering and Materials Science, Duke University, Durham, North Carolina., Spotnitz WD; Biom'up SA, Lyon, France.; Department of Surgery, University of Virginia, Charlottesville, Virginia.
Jazyk: angličtina
Zdroj: Journal of cardiac surgery [J Card Surg] 2020 Feb; Vol. 35 (2), pp. 313-319. Date of Electronic Publication: 2019 Nov 25.
DOI: 10.1111/jocs.14376
Abstrakt: 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.
(© 2019 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals, Inc.)
Databáze: MEDLINE
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