Middle Meningeal Artery Embolization with n-Butyl Cyanoacrylate for the Treatment of Subdural Hematomas: The MEMBRANE Study Design

Middle meningeal artery embolization with a liquid embolic is a minimally invasive adjunctive endovascular treatment for chronic subdural hematoma (cSDH). TRUFILL n-butyl cyanoacrylate Liquid Embolic System provides a possible option for middle meningeal artery embolization. The aim of this study is to evaluate safety/effectiveness of TRUFILL n-butyl cyanoacrylate versus standard-of-care alone for middle meningeal artery embolization in patients with cSDH.

MEMBRANE (Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL n-BCA) is a prospective, multicenter, open-label, randomized-controlled trial enrolling ∼376 adults at ∼35 sites in the United States and China. Site physicians will determine whether participants will undergo surgery or nonsurgical management. After demonstrating cSDH stability, participants will be randomized within the surgical or nonsurgical cohort to receive standard-of-care with/without TRUFILL n-butyl cyanoacrylate middle meningeal artery embolization, with follow-ups at 1, 3, 6, and 12 months post procedure.

Primary effectiveness end point is the occurrence of residual or re-accumulation of hematoma (>10 mm) at 6 months (assessed by independent imaging core laboratory) or reoperation/surgical procedure on the hematoma within 6 months. The primary safety end point is the occurrence of all adverse events through 6 months. Other end points include good functional outcome at 3 months (modified Rankin scale score: 0-2 or no worsening from baseline if baseline modified Rankin scale score ≥3); change in hematoma volume; complete cSDH resolution; development of acute component or new cSDH; requirement for cSDH surgery; death, stroke, myocardial infarction, or thromboembolic complications; new-onset seizures; change in modified Rankin Scale/Markwalder Grading Scale scores; quality of life; and healthcare resource use.

Results will provide valuable information on the safety/effectiveness of TRUFILL n-butyl cyanoacrylate as a minimally invasive standalone or adjunct treatment for cSDH.

http://clinicatrials.gov; Identifier: NCT04816591.