Embolisering av mellersta meningealartären för behandling av subdurala hematom med TRUFILL® n-BCA (MEMBRANE)
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).
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
This is a prospective, multi-center, open-label, randomized controlled study in which up to 376 subjects will be randomized to receive standard of care (SOC) alone or SOC and TRUFILL n-BCA MMA embolization for the treatment of cSDH.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Förenta staterna, 85710
- Carondelet St Joseph's Hospital
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California
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Walnut Creek, California, Förenta staterna, 94598
- John Muir Physician Network Clinical Research Center
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Colorado
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Englewood, Colorado, Förenta staterna, 80113
- Swedish Medical Center
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Connecticut
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Hartford, Connecticut, Förenta staterna, 06032
- Hartford Hospital
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New Haven, Connecticut, Förenta staterna, 06510
- Yale University
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20037
- George Washington University
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Florida
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Jacksonville, Florida, Förenta staterna, 32207
- Baptist Medical Center
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Miami, Florida, Förenta staterna, 33136
- University of Miami - Jackson Memorial Hospital
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Orlando, Florida, Förenta staterna, 32803
- Advent Health Orlando
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Georgia
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Atlanta, Georgia, Förenta staterna, 30309
- Piedmont Hospital
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Marietta, Georgia, Förenta staterna, 30067
- Wellstar Health System
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Savannah, Georgia, Förenta staterna, 31405
- Memorial Health University Health Center
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland
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Massachusetts
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Burlington, Massachusetts, Förenta staterna, 02115
- Lahey Hospital & Medical Center
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota
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New York
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New York, New York, Förenta staterna, 10029
- Mount Sinai Hospital
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Valhalla, New York, Förenta staterna, 10595
- Westchester Medical Center
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45267
- University of Cincinnati
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Columbus, Ohio, Förenta staterna, 43214
- Ohio Health
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Toledo, Ohio, Förenta staterna, 43608
- Mercy Health St Vincent Medical Center
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Oregon
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Portland, Oregon, Förenta staterna, 97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Hospital of the University of Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15212
- Allegheny General Hospital of Research
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38120
- Semmes Murphey Foundation
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Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt University Medical Center
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Texas
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Plano, Texas, Förenta staterna, 75075
- Texas Stroke Institute
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Utah
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Salt Lake City, Utah, Förenta staterna, 84132
- University of Utah
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908
- University of Virginia School of Medicine
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West Virginia
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Morgantown, West Virginia, Förenta staterna, 26506
- West Virginia Hospital
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Nanjing, Kina, 210008
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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Shanghai, Kina, 200127
- Renji Hospital, Shanghai Jiaotong University School of Medicine
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Pre-randomization mRS </= 3
- Confirmed diagnosis of chronic subdural hematoma
- Completed informed consent
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Experimental: Interventional Cohort: Treatment Arm
Standard of Care Surgery + Embolization |
Standard of Care Surgery + Embolization |
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Aktiv komparator: Standard of Care Surgery Only
Standard of Care Surgery Only |
Standard of Care Surgery Only |
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Experimentell: Interventional Cohort: Treatment Arm
Standard of Care Medical Management + Embolization |
Standard of Care Medical Management + Embolization |
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Aktiv komparator: Standard of Care Medical Management Only
Standard of Care medical management only. |
Standard of Care Medical Management Only |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: At 6 months
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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
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Percentage of Participants With All Adverse Events (AEs)
Tidsram: From randomization up to 6 months
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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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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)
Tidsram: At Month 3
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Participants were considered to have a good functional outcome if the 3-month mRS was less than or equal to (<=) 2 or otherwise no worsening from baseline mRS if the baseline mRS was >=3. mRS was used to assess the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scales ranges from 0-6, as follows: 0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead; higher values reflecting more severe disability or death. |
At Month 3
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Change From Baseline in Hematoma Volume at 3, 6 and 12 Months, as Assessed by an Independent Core Laboratory
Tidsram: Baseline, Months 3, 6 and 12
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Hematoma volume was assessed by independent core laboratory. An independent imaging core laboratory was utilized to provide an unbiased and standardized assessment of study imaging. Hematoma volume was calculated using the ABC/2 method (multiplying Diameters A, B, and C and dividing by 2), where Diameter A was defined as the largest length in the axial plane to each corner of the SDH, Diameter B was defined as the maximum with 90 degree to Diameter A in the same slice, Diameter C was defined as the maximum height of the hematoma. For the calculation of the height, the number of slices with visible hematoma was multiplied by the thickness of the CT-scan. Change from baseline was defined as: post-baseline value minus baseline value, with negative values indicating improvement with respect to baseline (a reduction in hematoma volume). Baseline was defined as the last non-missing measurement collected prior to randomization. |
Baseline, Months 3, 6 and 12
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Number of Participants With Greater Than (>) 50 Percent (%) Reduction in Hematoma Volume at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory
Tidsram: Month 3, Month 6 and Month 12
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Hematoma volume was assessed by independent core laboratory. An independent imaging core laboratory was utilized to provide an unbiased and standardized assessment of study imaging. Hematoma volume was calculated using the ABC/2 method (multiplying Diameters A, B, and C and dividing by 2), where Diameter A was defined as the largest length in the axial plane to each corner of the SDH, Diameter B was defined as the maximum with 90 degree to Diameter A in the same slice, Diameter C was defined as the maximum height of the hematoma. For the calculation of the height, the number of slices with visible hematoma was multiplied by the thickness of the CT-scan. Hematoma volume reduction (%) was calculated as: (post-baseline hematoma volume minus baseline volume) divided by baseline volume *100%. A reduction >50% was defined as a decrease in hematoma volume of more than half compared with baseline. Baseline was defined as the last non-missing measurement collected prior to randomization. |
Month 3, Month 6 and Month 12
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Number of Participants With Complete Resolution of the cSDH at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory
Tidsram: At Months 3, 6 and 12
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Number of participants with complete resolution of the cSDH at 3, 6, and 12 months as assessed by an independent core laboratory was reported. Complete resolution was defined as the absence of measurable cSDH on CT imaging, with no residual collection visible on the evaluated slices. |
At Months 3, 6 and 12
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Median Time to Achieve Complete Resolution of the cSDH
Tidsram: From baseline up to Month 12
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Median time to achieve complete resolution was estimated as the time point corresponding to a 50% probability of resolution of the cSDH based on the core laboratory evaluations. cSDH was evaluated using CT imaging reviewed by an independent blinded core laboratory. Complete resolution was defined as the absence of measurable cSDH on CT imaging. Time to complete resolution was calculated as the number of days from baseline to the first imaging assessment demonstrating complete resolution. |
From baseline up to Month 12
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Percentage of Participants Who Developed an Acute Component of Their Existing cSDH or a New cSDH (Kaplan-Meier Estimate) at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory
Tidsram: At Months 3, 6, and 12
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Percentage of participants who developed an acute component of their existing cSDH or a new cSDH at 3, 6, and 12 months as assessed by an independent core laboratory was reported. The first incidence of an acute component of an existing cSDH or a new cSDH was considered as event. Percentages reported are Kaplan-Meier estimates of cumulative incidence. |
At Months 3, 6, and 12
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Percentage of Participants Who Required a Surgical Procedure on the cSDH (Kaplan-Meier Estimate) Within 3 and 6 Months Post-Randomization
Tidsram: From randomization up to Months 3 and 6
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Participants who underwent re-operation or surgical procedure on the cSDH within 3 and 6 months post randomization were reported. Percentages reported are Kaplan-Meier estimates of cumulative incidence. |
From randomization up to Months 3 and 6
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Number of Participants Who Required More Than One Surgical Procedure on the cSDH Within 3, 6, and 12 Months Post-Randomization
Tidsram: From randomization up to Months 3, 6 and 12
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Number of participants who required more than one surgical procedure on the cSDH within 3, 6, and 12 months post-randomization were reported. |
From randomization up to Months 3, 6 and 12
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Number of Participants Who Required a Surgical Procedure on the cSDH Within 12 Months
Tidsram: From randomization up to Month 12
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Number of participants who required a surgical procedure on the cSDH within 12 months were reported. |
From randomization up to Month 12
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Number of Participants With Shift From Baseline in Modified Rankin Scale (mRS) Score at 3, 6, and 12 Months
Tidsram: Baseline, Months 3, 6 and 12
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mRS was used to assess the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scales ranges from 0-6, as follows: 0 = No symptoms; 1 = No significant disability. Able to carry out all usual activities, despite some symptoms; 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities; 3 = Moderate disability. Requires some help, but able to walk unassisted; 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted; 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent; 6 = Dead; higher values reflecting more severe disability or death. Baseline was defined as the last non-missing measurement collected prior to randomization. |
Baseline, Months 3, 6 and 12
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Number of Participants With Death, Stroke, Myocardial Infarction (MI) or Thromboembolic Complications Within 6 and 12 Months as Assessed by the Clinical Events Committee (CEC)
Tidsram: From randomization up to Months 6 and 12
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Number of participants with death, stroke, MI or thromboembolic complications within 6 and 12 months as assessed by the CEC were reported. |
From randomization up to Months 6 and 12
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Percentage of Participants With New Onset of Seizures (Kaplan-Meier Estimate) Within 3, 6, and 12 Months as Assessed by the Clinical Events Committee (CEC)
Tidsram: From randomization up to Months 3, 6, and 12
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Percentage of participants with new onset of seizures within 3, 6, and 12 months as assessed by the CEC were reported. Percentages reported are Kaplan-Meier estimates of cumulative incidence. |
From randomization up to Months 3, 6, and 12
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Number of Participants With Shift From Baseline in Mini-Mental State Exam (MMSE) Score at 6 Months
Tidsram: Baseline, 6 months
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MMSE was a standardized tool to assess mental state in elderly patients. It included tests of orientation, attention, memory, language, and visual-spatial skills. It is comprised of questions (For example (e.g.), "What is the year?") and tasks (e.g., "Make up and write a sentence about anything"). MMSE scores range between 0 and 30. Scores 0-17 indicated severe cognitive impairment, scores 18-23 indicated mild impairment, and scores 24-30 were considered normal. Higher scores indicated better cognitive function. Baseline was defined as the last non-missing measurement collected prior to randomization. |
Baseline, 6 months
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Number of Participants With Shift From Baseline in Markwalder Neurological Grading Scale (MGS) at 3, 6, and 12 Months
Tidsram: Baseline, Months 3, 6 and 12
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Number of participants with shift from baseline in MGS at 3, 6, and 12 months was reported. The MGS is a grading system developed to evaluate neurological performance in patients with cSDH. MGS is a 5 point scale ranging from 0 to 4, where lower scores indicate less neurological impairment and higher scores indicate greater impairment. The scale is defined as follows: Grade 0: patient neurologically normal; Grade 1: patient alert and oriented with mild symptoms such as headache or mild neurologic deficit; Grade 2: patient drowsy or disoriented with variable neurologic deficit; Grade 3: patient stuporous but responsive to noxious stimuli with focal neurologic signs; and Grade 4: patient comatose with absent motor response to painful stimuli. Baseline was defined as the last non-missing measurement collected prior to randomization. |
Baseline, Months 3, 6 and 12
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Hospital Days and Intensive Care Unit (ICU) Days
Tidsram: From randomization up to 6 months
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Hospital days included total length of stay in hospital (including ICU) for index procedure. ICU days included length of stay at ICU during hospitalizations for index procedure. |
From randomization up to 6 months
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Change From Baseline in EuroQol-5 Dimension-5 Levels (EQ-5D-5L) Score at 6 Months
Tidsram: Baseline, Month 6
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The EQ-5D-5L measured self-assessed health-related quality of life based on five categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each area was rated on a scale that described the degree of problems in that area (that is (i.e.)., "I had no problems walking about," "slight problems," "moderate problems," "severe problems," or "unable to walk"). This tool also had an overall health scale ranged from 1 to 100 to describe the condition of their health, 100 being the best imaginable. Higher scores indicating better QoL. Baseline was defined as the last non-missing measurement collected prior to randomization. |
Baseline, Month 6
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Ansaar Rai, MD, West Virginia University
- Huvudutredare: Christopher Kellner, MD, MOUNT SINAI HOSPITAL
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- Kellner CP, Rai AT, Shoirah H, Srinivasan VM, Gupta R, Starke RM, Al-Mufti F, Matouk CC, Yim B, Fusco MR, Wan J, Liptrap E, Bhuva P, Grandhi R, Cerejo R, Liu JJ, Cherian J, Zhang Q, Kaminsky I, Prestigiacomo CJ, Orru' E, Lin E, Howington J, Evans A, Mehta T, Boo S, Finch I, Liu T, Chitale R, Majidi S, Jankowitz BT; MEMBRANE Study Group. Middle Meningeal Artery Embolization With n-Butyl Cyanoacrylate in Patients With Chronic Subdural Hematoma: A Randomized Clinical Trial. JAMA Neurol. 2026 Aug 1;83(8):749-758. doi: 10.1001/jamaneurol.2026.1542.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Cerebrovaskulära störningar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Kärlsjukdomar
- Hjärt-kärlsjukdomar
- Sår och skador
- Patologiska processer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Blödning
- Kraniocerebralt trauma
- Trauma, nervsystemet
- Intrakraniella blödningar
- Intrakraniell blödning, traumatisk
- Patologiska tillstånd, tecken och symtom
- Hematom, Subdural
- Hematom
- Hematom, Subdural, Kronisk
Andra studie-ID-nummer
- CNV_2020_01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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
Läkemedels- och apparatinformation, studiedokument
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