Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial

• Authors: Mubashir Mumtaz, UPMC Pinnacle Health System; Richard B Thompson, Bryan Heart, Lincoln; Marc R Moon, Baylor College of Medicine; Ibrahim Sultan, UPMC Pittsburgh; T. Brett Reece, University of Colorado; William B Keeling, Emory University; Jacob DeLaRosa, Portneuf Medical Center,Pocatello
• Journal Title: JTCVS Open
• Volume: Volume 14
• Publisher: Elsevier Inc | 2023-06-01, Pages 134-144
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1016/j.xjon.2023.03.016
• Subjects: Health Sciences, Medicine and Surgery
• Keywords: bleeding control; clinical trial; hemostatic device; kaolin; time to hemostasis

Abstract

Objective: A kaolin-based nonresorbable hemostatic gauze, QuikClot Control+, has demonstrated effective hemostasis and safety when used for severe/life-threatening (grade 3/4) internal organ space bleeding. We evaluated the efficacy and safety of this gauze for mild to moderate (grade 1-2) bleeding in cardiac surgery compared with control gauze. Methods: This was a randomized, controlled, single-blinded study of patients who underwent cardiac surgery between June 2020 and September 2021 across 7 sites with 231 subjects randomized 2:1 to QuikClot Control+ or control. The primary efficacy end point was hemostasis rate (ie, subjects achieving grade 0 bleed) through up to 10 minutes of bleeding site application, assessed using a semiquantitative validated bleeding severity scale tool. The secondary efficacy end point was the proportion of subjects achieving hemostasis at 5 and 10 minutes. Adverse events, assessed up to 30 days postsurgery, were compared between arms. Results: The predominant procedure was coronary artery bypass grafting, and 69.7% and 29.4% were sternal edge and surgical site (suture line)/other bleeds, respectively. Of the QuikClot Control+ subjects, 121 of 153 (79.1%) achieved hemostasis within 5 minutes, compared with 45 of 78 (58.4%) controls (P < .001). At 10 minutes, 137 of 153 patients (89.8%) achieved hemostasis compared with 52 of 78 controls (68.4%) (P < .001). At 5 and 10 minutes, hemostasis was achieved in 20.7% and 21.4% more QuikClot Control+ subjects, respectively, compared with controls (P < .001). There were no significant differences in safety or adverse events between treatment arms. Conclusions: QuikClot Control+ demonstrated superior performance in achieving hemostasis for mild to moderate cardiac surgery bleeding compared with control gauze. The proportion of subjects achieving hemostasis was more than 20% higher in QuikClot Control+ subjects at both timepoints compared with controls, with no significant difference in safety outcomes.