Middle meningeal artery embolization for chronic subdural hematoma trials
A proposed trial aimed to conduct a head-to-head comparison between neurosurgical and endovascular treatment as stand-alone treatments.
The trial is academically driven and funded within existing public healthcare systems and infrastructure. Patients with uni- or bilateral cSDH, presenting with mild-to moderate symptoms, and admitted to neurosurgery on clinical grounds will be offered participation. Subjects are randomized 1:1 between conventional neurosurgical treatment (control) and endovascular embolization of the middle meningeal artery (intervention). Primary endpoint is reoperation due to clinically and/or radiologically significant recurrence within 3 months. Secondary endpoints include safety, technical success rate, neurological disability, and quality of life.
There are mounting retrospective data suggesting eMMA, as sole treatment or as an adjunctive to neurosurgery for cSDH, is safe and effective with a reoperation rate lower than neurosurgical hematoma evacuation alone. If randomized controlled trials confirm these findings, there is a potential for a paradigm shift in the treatment of cSDH where a minimally invasive procedure can replace open surgery in a large and oftentimes old and fragile patient cohort.
Trial registration: ClinicalTrials.gov, ClinicalTrials.gov Identifier NCT05267184 . Registered March 4, 2022 2).
MEMBRANE is an investigator-initiated, single-center, randomized controlled trial. Male, female, and diverse patients older than 18 years scheduled for surgical evacuation of a first chronic subdural hematoma will be assigned in a 1:1 fashion by block randomization to the chronic subdural hematoma treatment (surgery plus endovascular MMA embolization) or the control group (surgery alone). The primary trial endpoint is chronic subdural hematoma recurrence within 3 months of follow-up after surgery. Secondary endpoints comprise neurological deficits assessed by the modified Rankin Scale (mRS) and recurrence- or intervention-associated complications (see Chronic subdural hematoma surgery complications) see Middle meningeal artery embolization for chronic subdural hematoma complications during 3 months of follow-up. Assuming a risk difference of 20% of rebleeding and surgical revision, a power of 80%, and a drop-out rate of 10%, 154 patients will be enrolled in this trial, employing an adaptive O’Brien-Fleming approach with a planned interim analysis halfway.
The MEMBRANE trial will provide the first clinical experimental evidence on the effectiveness of endovascular embolization of the MMA as an adjunct to surgery to reduce the risk of recurrence after the evacuation of cSDH.
Trial registration: German Clinical Trials Registry (Deutsches Register Klinischer Studien [DRKS]) DRKS00020465. Registered on 18 Nov 2021 3).