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.
背景：止血产品在肝切除术中被广泛用于控制出血。Stopad是一种垫型止血剂，含有羧甲基壳聚糖和重组类凝血酶血凝酶。方法：我们对104名需行开腹肝切除术的患者进行了一项前瞻性、多中心、随机、非劣效性研究，比较Stopad与Tachosil的止血效果。受试者按1:1比例随机分配至研究组（Stopad；53例）或对照组（Tachosil；51例）。结果：Stopad组的3分钟出血控制成功率为92.45%，Tachosil组为90.20%。两组成功率差异的单侧97.5%置信区间下限为-9.82%，在预设的非劣效界值-22.9%之内。Stopad组的5分钟和10分钟出血控制成功率均为100.00%，Tachosil组均为98.04%。Stopad组不良事件发生率（29/53，54.72%）显著高于Tachosil组（17/51，33.33%；p=0.0282）。然而，Stopad组不良事件较多可能与该组有手术或介入治疗史的患者比例较高有关。结论：在接受开腹肝切除术的患者中，Stopad的止血效果不劣于Tachosil，这为未来开发更高效的止血产品提供了新的可能性。试验注册号：KCT0004404。
肿瘤(癌症)患者之家