Reply to the article: 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. Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations. J Card Surg. 2019;1-7. DOI: 10.1111/jocs.14376

Autor: Daniel Spazierer, Gerhard Moersdorf
Rok vydání: 2020
Předmět:
Zdroj: Journal of Cardiac Surgery
ISSN: 1540-8191
Popis: 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
Databáze: OpenAIRE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje