Evidence map›Paper›PMID 41608724›Full record

ArticleStroke (Hoboken, N.J.)2025

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

Christopher P Kellner, Fawaz Al-Mufti, Rishi Gupta, Brian T Jankowitz, Robert M Starke, Ansaar T Rai

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Stroke (Hoboken, N.J.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04816591 (Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT04816591 nacompletednot on this map

Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA

TypeinterventionalSponsorCerenovus, Part of DePuy Synthes Products, Inc.Ran2021 to 2025Enrolled376ConditionsChronic Subdural HematomaArmsExperimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System, Standard of Care Surgery, Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System, Standard of Care Medical Management
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
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

6 authors.

Christopher P KellnerMount Sinai Health System Department of Neurosurgery New York NY.ORCID https://orcid.org/0000-0003-4604-8205
Fawaz Al-MuftiWestchester Medical Center Valhalla NY.ORCID https://orcid.org/0000-0003-4461-7005
Rishi GuptaWellStar Health System Marietta GA.ORCID https://orcid.org/0000-0003-1505-2498
Brian T JankowitzJFK University Medical Center Edison NJ.ORCID https://orcid.org/0000-0001-9306-0763
Robert M StarkeUniversity of Miami, Jackson Memorial Hospital Miami FL.
Ansaar T RaiDepartment of Neuroradiology Rockefeller Neuroscience Institute West Virginia University Morgantown WV.ORCID https://orcid.org/0000-0001-9864-4805

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMiddle 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.

methodsMEMBRANE (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.

resultsPrimary 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.

conclusionResults will provide valuable information on the safety/effectiveness of TRUFILL n-butyl cyanoacrylate as a minimally invasive standalone or adjunct treatment for cSDH. Clinical Trial Registration Information: http://clinicatrials.gov; Identifier: NCT04816591.

Identifiers

PMID41608724
PMCPMC12697590

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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.