Related Experiment Video
Updated: Aug 31, 2025
Minimally Invasive Endoscopic Intracerebral Hemorrhage Evacuation
Published on: October 15, 2021
Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural
Alexander Hoenning1, Johannes Lemcke2, Sergej Rot2
1Center for Clinical Research, BG Klinikum Unfallkrankenhaus Berlin, Warener Str. 7, 12683, Berlin, Germany. alexander.hoenning@ukb.de.
Insights
The MEMBRANE trial investigates if embolizing the middle meningeal artery (MMA) after surgery reduces chronic subdural hematoma (cSDH) recurrence. This study will offer key evidence on MMA embolization
Area of Science:
- Neurosurgery
- Interventional Radiology
- Clinical Trials
Background:
- Chronic subdural hematoma (cSDH) is a common complication of mild traumatic brain injury, often requiring neurosurgery.
- Current surgical evacuation has a significant rebleeding rate (up to 33%), necessitating further interventions.
- Adjunct endovascular embolization of the middle meningeal artery (MMA) is a potential strategy to reduce cSDH recurrence.
Purpose of the Study:
- To evaluate the effectiveness of endovascular MMA embolization as an adjunct to surgical evacuation in reducing cSDH recurrence.
- To compare the recurrence rates between patients receiving surgery plus MMA embolization and those receiving surgery alone.
Main Methods:
- The MEMBRANE trial is a single-center, randomized controlled trial with 1:1 allocation.
- Patients undergoing surgical evacuation for a first cSDH are randomized to either surgery plus MMA embolization or surgery alone.
- The primary endpoint is cSDH recurrence within 3 months; secondary endpoints include neurological deficits and complications.
Main Results:
- The MEMBRANE trial is currently enrolling patients and has not yet reported results.
- The study aims to enroll 154 patients, with an interim analysis planned.
Conclusions:
- The MEMBRANE trial is expected to provide the first clinical experimental evidence on the efficacy of MMA embolization in preventing cSDH recurrence.
- Findings will inform clinical practice regarding the use of endovascular techniques to improve outcomes after cSDH surgery.
Background:
Chronic subdural hematoma (cSDH) is the most common complication of mild traumatic brain injury demanding neurosurgery in high-income countries. If undetected and untreated, cSDH may increase intracranial pressure and cause neurological deficiencies. The first-line intervention of choice is burr hole trepanation and hematoma evacuation. However, any third patient may experience rebleeding, demanding craniotomy with excess morbidity. Adjunct endovascular embolization of the frontal and parietal branches of the middle meningeal artery (MMA) is a promising approach to avoid relapse and revision but was hitherto not studied in a randomized trial.
Methods:
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 cSDH will be assigned in a 1:1 fashion by block randomization to the intervention (surgery plus endovascular MMA embolization) or the control group (surgery alone). The primary trial endpoint is cSDH 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 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 onto this trial, employing an adaptive O'Brien-Fleming approach with a planned interim analysis halfway.
Discussion:
The MEMBRANE trial will provide 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.
Clinicaltrials:
gov NCT05327933 . Registered on 13 Apr 2022.
