OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.