ArticleCVIR endovascular2025
A multicenter prospective study evaluating use of EmboCube™ Embolization Gelatin alone or in combination with other embolic agents to control bleeding.
Article in CVIR endovascular, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05307783 (A Multicenter Observational Study to Evaluate Outcomes of EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging), which is not on this map. Not yet cited in PubMed.
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A Multicenter Observational Study to Evaluate Outcomes of EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging
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6 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundEmbolization 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.
methodsThis 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.
resultsA 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).
conclusionEmboCube 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 registrationClinicaltrials.gov. Registered 23 March 2022, https://clinicaltrials.gov/study/NCT05307783 .
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