Abstract
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.
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Details
1 BG Klinikum Unfallkrankenhaus Berlin, Center for Clinical Research, Berlin, Germany (GRID:grid.460088.2) (ISNI:0000 0001 0547 1053)
2 BG Klinikum Unfallkrankenhaus Berlin, Department of Neurosurgery, Berlin, Germany (GRID:grid.460088.2) (ISNI:0000 0001 0547 1053)
3 BG Kliniken – Klinikverbund der Gesetzlichen Unfallversicherung gGmbH, Berlin, Germany (GRID:grid.460088.2)
4 BG Klinikum Unfallkrankenhaus Berlin, Institute of Laboratory Medicine, Berlin, Germany (GRID:grid.460088.2) (ISNI:0000 0001 0547 1053)
5 BG Klinikum Unfallkrankenhaus Berlin, Department of Radiology and Neuroradiology, Berlin, Germany (GRID:grid.460088.2) (ISNI:0000 0001 0547 1053); University Medicine Greifswald, Institute for Diagnostic Radiology and Neuroradiology, Greifswald, Germany (GRID:grid.5603.0)