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

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.