75\u2005A prospective, multi-center, randomized controlled pivotal study to evaluate the safety and effectiveness of trufill® NBCA embolization of the middle meningeal artery for the treatment of subdural hematoma – The membrane study

Abstract

Introduction Chronic subdural hematoma (cSDH) is one of the most common neurosurgical diseases with an incidence of 1-5.3 cases per 100,000 that increases significantly with age. When symptomatic, these lesions are often treated by surgery, an approach which does not directly address the underlying pathophysiology of chronic inflammation and neovascularization of the dura and has a high incidence of recurrence. Middle meningeal artery (MMA) embolization has emerged as a potential minimally invasive endovascular treatment option that may substitute for surgery or serve as an adjunct. TRUFILL n-BCA is potentially well suited as a liquid embolic in this procedure given that it is non-caustic, rapidly deployed, and able to be injected in a highly targeted fashion. Here we present the protocol for a randomized clinical trial to evaluate the safety and effectiveness of n-BCA embolization of the MMA for the treatment of cSDH. Methods This investigational trial is a prospective, multi-center, open-label, randomized controlled study in which up to 376 subjects will be randomized to receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of cSDH. The study is designed to evaluate the effectiveness and safety of MMA in two cohorts - a surgical cohort and a non-surgical cohort. Results Study EndpointsThe primary study effectiveness endpoint is the incidence of residual or re-accumulation of the cSDH (>10 mm) at 6 months as assessed by an independent core laboratory OR re-operation or surgical procedure on the hematoma within 6 months post randomization. Secondary effectiveness endpoints include mean reduction of hematoma volume at 3, 6 and 12 months compared to baseline, reduction > 50% in hematoma volume at 3, 6 and 12 months as well as others. Secondary safety endpoints include death, stroke, myocardial infarction or thromboembolic complications within 3, 6 and 12 months as well as others. Secondary health economics endpoints include hospital days, intensive care unit days, and change in the EQ-5D-5L score at discharge and 6 months compared to baseline. Conclusion Middle meningeal artery embolization with n-BCA is an emerging treatment strategy for cSDH. An appropriately powered trial like the MEMBRANE Study will provide high level evidence on the potential safety and efficacy of this treatment paradigm. Disclosures C. Kellner: 1; C; Penumbra, Siemens, Cerebrotech, Viz.AI, Minnetronix. 4; C; Metis Innovative. F. Al-Mufti: None. R. Gupta: None. B. Jankowitz: None. R. Starke: None. A. Rai: None.