Safety and efficacy of HLBLS-200 (BleeFix) as a novel hemostatic agent in hepatic surgery: a multicenter, randomized, active-controlled clinical trial

초록

Purpose: This study aimed to evaluate the safety and efficacy of HLBLS-200 (BleeFix, HLB Cell Co., Ltd.) in patients requiring hemostasis for exudative bleeding following primary hemostasis during hepatic resection. Methods: This prospective, randomized controlled clinical trial was conducted at three hospitals in South Korea, with Arista AH (Becton Dickinson) serving as the active comparator. A total of 156 patients who underwent elective liver resection with exudative bleeding were randomized. The primary endpoint was the hemostasis success rate within 5 minutes of application. Secondary endpoint included hemostatic success rates at 3, 4, 7, and 10 minutes. Safety was assessed by monitoring adverse events over a 12-week follow-up period. Results: The hemostatic success rate within 5 minutes was 98.5% (66/67) in the BleeFix group and 97.0% (65/67) in the control group. The between-group difference was 1.49% (95% confidence interval [CI], -5.72% to 9.07%). The lower bound of the CI (-5.72%) exceeded the predefined non-inferiority margin of -15.00%, confirming the non-inferiority of BleeFix. Treatment-emergent adverse events (TEAEs) were more frequent in the BleeFix group (97.44% vs. 87.18%, P = 0.016), with most events classified as mild (grade 1). This difference may be partially attributed to a statistically significant variation in sex distribution between groups. Serious TEAEs occurred in four participants, with no statistically significant differences between groups. Conclusion: BleeFix demonstrated non-inferior hemostatic efficacy compared with Arista AH during hepatectomy. These findings support the clinical use of BleeFix as a safe and effective hemostatic agent for managing exudative bleeding during hepatic resection.

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