A multicenter prospective study evaluating use of EmboCube™ Embolization Gelatin alone or in combination with other embolic agents to control bleeding.

Abstract

Background: Embolization is a vital endovascular procedure that can be used to quickly achieve hemostasis in patients experiencing uncontrolled bleeding. This study was conducted to describe real-world outcomes following embolization with a pre-cut absorbable gelatin sponge to control bleeding.

Methods: This prospective study was conducted across five hospitals in Australia and France. Inclusion criteria included adults ≥ 18 years who required embolization with EmboCube™ Embolization Gelatin for bleeding. Primary performance and safety endpoints were the proportion of patients that achieved clinical success (i.e., cessation of bleeding post-embolization, the absence of rebleeding at the treated site requiring reintervention within 24 h), and the absence of unanticipated serious adverse device effects within 24 h of the initial embolization, respectively. Secondary endpoints included technical success and serious device- and/or procedure-related adverse events 28 days post-initial embolization.

Results: A total of 101 patients (54 males) were enrolled and treated. Sixty-six patients were treated with EmboCube only, 35 patients were treated with an additional embolic to control bleeding. Technical and clinical success rates were 100% and 99%, respectively. No patient experienced an unanticipated serious event related to the embolic. The mean time to hemostasis was 3.4 (± 3.96) minutes. Of the 90 patients that completed 28 days of follow-up, 4 (4.4%) experienced an adverse event (access site hematoma, n = 2; ischemic colitis, n = 1, peritonitis, n = 1).

Conclusion: EmboCube is safe and effective for control of acute and sub-acute arterial bleeding, alone or in combination with other embolic agents, when rapid hemostasis is required.

Trial registration: Clinicaltrials.gov. Registered 23 March 2022, https://clinicaltrials.gov/study/NCT05307783 .