Evidence map›Paper›PMID 35996195›Full record

ArticleTrials2022

Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE): study protocol for a randomized controlled trial.

Alexander Hoenning, Johannes Lemcke, Sergej Rot, Dirk Stengel, Berthold Hoppe, Kristina Zappel, Patrick Schuss, Sven Mutze, Leonie Goelz

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05327933 (Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05327933 narecruitingnot on this map

Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)

TypeinterventionalSponsorUnfallkrankenhaus BerlinRan2022 to 2025Enrolled154ConditionsHematoma, Subdural, ChronicArmsSurgery plus endovascular MMA embolization, Surgery alone
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

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  8. N-butyl Cyanoacrylate Use in Various Neuroendovascular Diseases.Journal of neuroendovascular therapy · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Alexander Hoenning *Center for Clinical Research, BG Klinikum Unfallkrankenhaus Berlin, Warener Str. 7, 12683, Berlin, Germany. alexander.hoenning@ukb.de.
Johannes Lemcke *Department of Neurosurgery, BG Klinikum Unfallkrankenhaus Berlin, Warener Str. 7, 12683, Berlin, Germany.
Sergej RotDepartment of Neurosurgery, BG Klinikum Unfallkrankenhaus Berlin, Warener Str. 7, 12683, Berlin, Germany.
Dirk StengelBG Kliniken - Klinikverbund der Gesetzlichen Unfallversicherung gGmbH, Leipziger Pl. 1, 10117, Berlin, Germany.
Berthold HoppeInstitute of Laboratory Medicine, BG Klinikum Unfallkrankenhaus Berlin, Warener Str. 7, 12683, Berlin, Germany.
Kristina ZappelCenter for Clinical Research, BG Klinikum Unfallkrankenhaus Berlin, Warener Str. 7, 12683, Berlin, Germany.
Patrick SchussDepartment of Neurosurgery, BG Klinikum Unfallkrankenhaus Berlin, Warener Str. 7, 12683, Berlin, Germany.
Sven MutzeDepartment of Radiology and Neuroradiology, BG Klinikum Unfallkrankenhaus Berlin, Warener Str. 7, 12683, Berlin, Germany.
Leonie GoelzDepartment of Radiology and Neuroradiology, BG Klinikum Unfallkrankenhaus Berlin, Warener Str. 7, 12683, Berlin, Germany.
Unfallkrankenhaus Berlin · DEDeutsche Gesetzliche Unfallversicherung · DE

Funding

Deutsche Gesetzliche Unfallversicherung FR-0341
6 · The paper itself

Abstract

backgroundChronic 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.

methodsMEMBRANE 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 registrationGerman Clinical Trials Registry (Deutsches Register Klinischer Studien [DRKS]) DRKS00020465. Registered on 18 Nov 2021. CLINICALTRIALS: gov NCT05327933 . Registered on 13 Apr 2022.

Indexed as

Embolization, TherapeuticHematoma, Subdural, ChronicCraniotomyFemaleHumansMaleMeningeal ArteriesRandomized Controlled Trials as TopicRecurrenceTreatment OutcomeChronic subdural hematomaEmbolizationEndovascularMild traumatic brain injuryRandomized controlled trialSurgery

Identifiers

PMID35996195
PMCPMC9396835
OpenAlexW4292607954

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.