A Prospective, Multicenter, Randomized, Noninferiority Trial of Stopad® Versus Tachosil® for Hemostasis After Liver Resection

Abstract

Background: Hemostatic products are widely used to control bleeding in hepatic resections. Stopad is a pad-type hemostatic agent containing carboxymethyl chitosan and recombinant thrombin-like hemocoagulase. Methods: We conducted a prospective, multicenter, randomized, noninferiority study of Stopad vs. Tachosil in 104 patients who required open hepatic resection. The subjects were randomized 1:1 to either the investigational group (Stopad; 53) or the control group (Tachosil; 51). Results: The 3-min bleeding control success rate was 92.45% in the Stopad group and 90.20% in the Tachosil group. The lower bound of the one-sided 97.5% confidence level for the between-group difference in the success rate was -9.82%, which was within the preset noninferiority limit of -22.9%. The 5- and 10-min bleeding control success rates were both 100.00% for the Stopad group and were both 98.04% in the Tachosil group. A significantly higher incidence of adverse events was reported in the Stopad group (29/53, 54.72%) than in the Tachosil group (17/51, 33.33%; p = 0.0282). However, the higher number of adverse events in the Stopad group was likely due to a higher proportion of subjects with a past history of surgical or interventional procedure. Conclusions: The hemostatic efficacy of Stopad was noninferior to that of Tachosil in patients undergoing open hepatic resection, introducing new possibilities for more potent hemostatic products in the future. Trial registration number: KCT0004404.