Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
MEMBRANE
1 other identifier
interventional
376
2 countries
33
Brief Summary
This is a prospective, multi-center, open-label, randomized controlled study in which subjects can receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of chronic subdural hematomas (cSDH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Longer than P75 for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2021
CompletedFirst Posted
Study publicly available on registry
March 25, 2021
CompletedStudy Start
First participant enrolled
May 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2025
CompletedResults Posted
Study results publicly available
February 24, 2026
CompletedMarch 13, 2026
March 1, 2026
3.2 years
March 23, 2021
January 14, 2026
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Residual or Re-accumulation of the Chronic Subdural Hematoma (cSDH) (Greater Than [>] 10 Millimeter [mm]) as Assessed by an Independent Core Laboratory OR Any Re-operation or Surgical Procedure on the cSDH at 6 Months
Percentage of participants and odds ratio (OR) of participants with residual or re-accumulation of the cSDH (\>10 mm) at 6 months as assessed by an independent core laboratory or re-operation or surgical procedure on the cSDH at 6 months post-randomization in the treatment with eMMA vs. standard of care is represented. Residual or re-accumulation of the cSDH \>10 mm was a threshold included in the guidelines for surgical evacuation and was considered to be of prognostic importance given its association with mortality, decreased quality of life, and complications from new or repeat procedures.
At 6 months
Percentage of Participants With All Adverse Events (AEs)
An AE was any untoward medical experience (sign, symptom, illness, abnormal laboratory value, or other medical event) occurring to a participant during the course of the study whether or not related to the investigational device. SAE was any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. All AEs including both serious and non serious were reported.
From randomization up to 6 months
Secondary Outcomes (16)
Number of Participants With Good Functional Outcome at 3 Months (Modified Rankin Score [mRS] 0-2 or no Worsening From Baseline if Baseline mRS Greater Than Equal to [>=] 3)
At Month 3
Change From Baseline in Hematoma Volume at 3, 6 and 12 Months, as Assessed by an Independent Core Laboratory
Baseline , Months 3, 6 and 12
Number of Participants With Greater Than (>) 50% Reduction in Hematoma Volume at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory
Month 3, Month 6 and Month 12
Number of Participants With Complete Resolution of the cSDH at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory
At Months 3, 6 and 12
Median Time to Achieve Complete Resolution of the cSDH
Up to 12 months
- +11 more secondary outcomes
Study Arms (4)
Experimental: Interventional Cohort: Treatment Arm
EXPERIMENTALStandard of Care Surgery + Embolization
Standard of Care Surgery Only
ACTIVE COMPARATORStandard of Care Surgery Only
Interventional Cohort: Treatment Arm
EXPERIMENTALStandard of Care Medical Management + Embolization
Standard of Care Medical Management Only
ACTIVE COMPARATORStandard of Care medical management only.
Interventions
Standard of Care Medical Management + Embolization
Standard of Care Medical Management Only
Standard of Care Surgery + Embolization
Eligibility Criteria
You may qualify if:
- Pre-randomization mRS \</= 3
- Confirmed diagnosis of chronic subdural hematoma
- Completed informed consent
You may not qualify if:
- Acute subdural hematoma
- Prior treatment of target subdural hematoma
- Markwalder assessment \>/= 3
- Glasgow Coma Scale \< 9
- Presumed microbial superinfection
- CT or MRI evidence of intracranial tumor or mass lesion
- Life expectancy \< 1 year
- Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study
- Current involvement in another clinical trial that may confound study endpoints
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Carondelet St Joseph's Hospital
Tucson, Arizona, 85710, United States
John Muir Physician Network Clinical Research Center
Walnut Creek, California, 94598, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Hartford Hospital
Hartford, Connecticut, 06032, United States
Yale University
New Haven, Connecticut, 06510, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Baptist Medical Center
Jacksonville, Florida, 32207, United States
University of Miami - Jackson Memorial Hospital
Miami, Florida, 33136, United States
Advent Health Orlando
Orlando, Florida, 32803, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Wellstar Health System
Marietta, Georgia, 30067, United States
Memorial Health University Health Center
Savannah, Georgia, 31405, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, 02115, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Ohio Health
Columbus, Ohio, 43214, United States
Mercy Health St Vincent Medical Center
Toledo, Ohio, 43608, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital of Research
Pittsburgh, Pennsylvania, 15212, United States
Semmes Murphey Foundation
Memphis, Tennessee, 38120, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Stroke Institute
Plano, Texas, 75075, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia School of Medicine
Charlottesville, Virginia, 22908, United States
West Virginia Hospital
Morgantown, West Virginia, 26506, United States
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, 210008, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200127, China
Related Publications (1)
Kellner CP, Al-Mufti F, Gupta R, Jankowitz BT, Starke RM, Rai AT. Middle Meningeal Artery Embolization with n-Butyl Cyanoacrylate for the Treatment of Subdural Hematomas: The MEMBRANE Study Design. Stroke Vasc Interv Neurol. 2025 Sep 17;5(6):e001828. doi: 10.1161/SVIN.125.001828. eCollection 2025 Nov.
PMID: 41608724DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study occurred during the COVID-19 pandemic, affecting participants' health and follow-up visits. The wide age range (up to 90 years) made follow-up challenging, especially for older participants reluctant to travel for CT scans. Measurements of clinical effectiveness (e.g., mRS) in cSDH participants were often suboptimal due to subtle presentations of neurological symptoms, but was still reported. There was also a lack of consensus on non-surgical management and medication regimens.
Results Point of Contact
- Title
- Medical Director
- Organization
- Johnson & Johnson MedTech
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Kellner, MD
MOUNT SINAI HOSPITAL
- PRINCIPAL INVESTIGATOR
Ansaar Rai, MD
West Virginia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2021
First Posted
March 25, 2021
Study Start
May 27, 2021
Primary Completion
August 15, 2024
Study Completion
March 26, 2025
Last Updated
March 13, 2026
Results First Posted
February 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu