Verbraeken Barbara, Plazier Mark, Put Eric, Meeuws Sacha, Roosen Gert, Ughratdar Ismail, Zisakis Athanasios, Vergani Francesco, Ganau Mario, Plaha Puneet, Apostolopoulos Vasileios, Feyen Bart, Raymaekers Vincent, Aboukais Rabih, Menovsky Tomas
Department of Neurosurgery, Antwerp University Hospital (UZA), Antwerp, Belgium; Department of Pathology, Antwerp University Hospital (UZA), Antwerp, Belgium; Faculty of Medicine and Health Sciences, University of Antwerp (UA), Antwerp, Belgium.
Department of Neurosurgery, Jessa Hospital, Limburg, Belgium.
World Neurosurg. 2025 May;197:123856. doi: 10.1016/j.wneu.2025.123856. Epub 2025 Mar 5.
This article describes the results of the first-in-human prospective clinical trial of a hemostatic hydrogel of the self-assembling peptide IEIK13 for hemostasis in intracranial surgery. Both safety and efficacy of IEIK13 for intraoperative hemostasis of oozing bleeding were evaluated in this multicenter trial.
A total of 80 participants underwent a surgical intervention, during which 203 intradural bleeding sites were treated with IEIK13. Hemostasis was evaluated at 30 seconds and again at 1, 2, 3, and 6 minutes after application. A performance goal of >70% of bleeding sites reaching hemostasis within 3 minutes after application of IEIK13 was used to demonstrate noninferiority in statistical analysis. Clinical safety evaluation was performed postoperatively, at hospital discharge, and at 1 and 3 months after surgery. This included follow-up radiological imaging within the first 72 hours postoperatively and at 3 months.
Hemostasis was achieved within 3 minutes in 94.1% of bleeding sites, and within 6 minutes in 95.6% of bleeding sites. Subanalysis revealed that hemostasis occurred within the first minute in 89.2% of cases. There were no intraoperative device deficiencies. Results of the safety assessment did not raise any specific concerns. The nature and rate of adverse events did not significantly differ from what is typically expected in neurosurgical practice.
IEIK13 is effective and safe for hemostasis of oozing bleeding during intracranial neurosurgery. Based on this trial, the transparent IEIK13 hydrogel is a useful addition to the neurosurgical hemostasis toolbox.
本文介绍了自组装肽IEIK13止血水凝胶用于颅内手术止血的首例人体前瞻性临床试验结果。在这项多中心试验中评估了IEIK13用于术中渗血止血的安全性和有效性。
共有80名参与者接受了手术干预，期间用IEIK13治疗了203个硬脑膜内出血部位。在应用后30秒以及1、2、3和6分钟再次评估止血情况。使用IEIK13应用后3分钟内>70%的出血部位实现止血的性能目标来证明统计分析中的非劣效性。术后、出院时以及术后1个月和3个月进行临床安全性评估。这包括术后72小时内和3个月时的随访影像学检查。
94.1%的出血部位在3分钟内实现止血，95.6%的出血部位在6分钟内实现止血。亚分析显示，89.2%的病例在第一分钟内实现止血。术中没有器械缺陷。安全性评估结果没有引起任何具体担忧。不良事件的性质和发生率与神经外科手术中的通常预期没有显著差异。
IEIK13在颅内神经外科手术中对渗血止血有效且安全。基于该试验，透明的IEIK13水凝胶是神经外科止血工具箱中的一个有用补充。
