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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Interventional Cohort: Treatment Arm | Experimental | Standard of Care Surgery + Embolization |
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| Standard of Care Surgery Only | Active Comparator | Standard of Care Surgery Only |
|
| Interventional Cohort: Treatment Arm | Experimental | Standard of Care Medical Management + Embolization |
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| Standard of Care Medical Management Only | Active Comparator | Standard of Care medical management only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System | Device | Standard of Care Surgery + Embolization |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Kellner, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Ansaar Rai, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Carondelet St Joseph's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42295790 | Derived | 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 Jun 15. doi: 10.1001/jamaneurol.2026.1542. Online ahead of print. | |
| 41608724 |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgical Cohort: Surgery + Middle Meningeal Artery Embolization (eMMA) | Participants who underwent a surgical procedure as standard of care (SOC) for chronic subdural hematoma (cSDH) decompression were randomized to eMMA. eMMA was performed using TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (TRUFILL n-BCA) within 10 days after the surgery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 25, 2024 | Jan 14, 2026 |
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| Standard of Care Surgery | Other | Standard of Care Surgery Only |
|
| Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System | Device | Standard of Care Medical Management + Embolization |
|
| Standard of Care Medical Management | Other | Standard of Care Medical Management Only |
|
| At Month 3 |
| Change From Baseline in Hematoma Volume at 3, 6 and 12 Months, as Assessed by an Independent Core Laboratory | 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 |
| 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 | 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 |
| Number of Participants With Complete Resolution of the cSDH at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory | 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 |
| Median Time to Achieve Complete Resolution of the cSDH | 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 |
| 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 | 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 |
| Percentage of Participants Who Required a Surgical Procedure on the cSDH (Kaplan-Meier Estimate) Within 3 and 6 Months Post-Randomization | 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 |
| Number of Participants Who Required More Than One Surgical Procedure on the cSDH Within 3, 6, and 12 Months Post-Randomization | 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 |
| Number of Participants Who Required a Surgical Procedure on the cSDH Within 12 Months | Number of participants who required a surgical procedure on the cSDH within 12 months were reported. | From randomization up to Month 12 |
| Number of Participants With Shift From Baseline in Modified Rankin Scale (mRS) Score at 3, 6, and 12 Months | 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 |
| 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) | 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 |
| 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) | 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 |
| Number of Participants With Shift From Baseline in Mini-Mental State Exam (MMSE) Score at 6 Months | 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 |
| Number of Participants With Shift From Baseline in Markwalder Neurological Grading Scale (MGS) at 3, 6, and 12 Months | 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 |
| Hospital Days and Intensive Care Unit (ICU) Days | 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 |
| Change From Baseline in EuroQol-5 Dimension-5 Levels (EQ-5D-5L) Score at 6 Months | 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 |
| 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 |
| Derived |
| 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. |
| FG001 |
| Surgical Cohort: Standard of Care: Surgery Only |
Participants who underwent a surgical procedure as SOC for cSDH decompression were randomized with no further intervention. |
| FG002 | Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA | Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| FG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
| Treated Analysis Set | Included all randomized participants in the study who received study treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Surgical Cohort: Surgery + Middle Meningeal Artery Embolization (eMMA) | Participants who underwent a surgical procedure as standard of care (SOC) for chronic subdural hematoma (cSDH) decompression were randomized to eMMA. eMMA was performed using TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (TRUFILL n-BCA) within 10 days after the surgery. |
| BG001 | Surgical Cohort: Standard of Care: Surgery Only | Participants who underwent a surgical procedure as SOC for cSDH decompression were randomized with no further intervention. |
| BG002 | Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA | Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| BG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Ethnicity | Count of Participants | Participants |
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| Modified Rankin Score (mRS) | mRS spans 0-6, 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, unable to walk unassisted; 5= Severe disability. Requires constant nursing care and attention, bedridden; 6= Dead; higher values reflecting more severe disability or death. | Count of Participants | Participants |
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| Markwalder Grading Scale (MGS) | Markwalder Neurological Grading Scale was a grading system developed to evaluate neurological performance in patients presenting with cSDH. It was a 5 point scale ranging from 0 (patient neurologically normal), through 1-3 (mild to severe neurological deficit), to 4 (patient comatose). Higher score indicated worse outcome. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Intent to treat (ITT) analysis set included all enrolled participants who were randomized in the study. | Posted | Number | Percentage of Participants | At 6 months |
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| Primary | 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. | As Treated (AT) analysis set included all randomized participants in the study who received study treatment. | Posted | Number | Percentage of participants | From randomization up to 6 months |
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| Secondary | 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) | 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. | ITT analysis set included all enrolled participants who were randomized in the study. | Posted | Count of Participants | Participants | At Month 3 |
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| Secondary | Change From Baseline in Hematoma Volume at 3, 6 and 12 Months, as Assessed by an Independent Core Laboratory | 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. | ITT analysis set included all enrolled participants who were randomized in the study. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Mean | Standard Deviation | cubic centimeters (cm^3) | Baseline, Months 3, 6 and 12 |
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| Secondary | 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 | 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. | ITT analysis set included all enrolled participants who were randomized in the study. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Count of Participants | Participants | Month 3, Month 6 and Month 12 |
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| Secondary | Number of Participants With Complete Resolution of the cSDH at 3, 6, and 12 Months as Assessed by an Independent Core Laboratory | 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. | ITT analysis set included all enrolled participants who were randomized in the study. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Count of Participants | Participants | At Months 3, 6 and 12 |
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| Secondary | Median Time to Achieve Complete Resolution of the cSDH | 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. | ITT analysis set included all enrolled participants who were randomized in the study. | Posted | Median | Full Range | Days | From baseline up to Month 12 |
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| Secondary | 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 | 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. | ITT analysis set included all enrolled participants who were randomized in the study. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Number | Percentage of participants | At Months 3, 6, and 12 |
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| Secondary | Percentage of Participants Who Required a Surgical Procedure on the cSDH (Kaplan-Meier Estimate) Within 3 and 6 Months Post-Randomization | 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. | ITT analysis set included all enrolled participants who were randomized in the study. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Number | Percentage of participants | From randomization up to Months 3 and 6 |
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| Secondary | Number of Participants Who Required More Than One Surgical Procedure on the cSDH Within 3, 6, and 12 Months Post-Randomization | Number of participants who required more than one surgical procedure on the cSDH within 3, 6, and 12 months post-randomization were reported. | ITT analysis set included all enrolled participants who were randomized in the study. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Count of Participants | Participants | From randomization up to Months 3, 6 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Required a Surgical Procedure on the cSDH Within 12 Months | Number of participants who required a surgical procedure on the cSDH within 12 months were reported. | ITT analysis set included all enrolled participants who were randomized in the study. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From randomization up to Month 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Shift From Baseline in Modified Rankin Scale (mRS) Score at 3, 6, and 12 Months | 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. | ITT analysis set included all enrolled participants who were randomized in the study. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Count of Participants | Participants | Baseline, Months 3, 6 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | Number of participants with death, stroke, MI or thromboembolic complications within 6 and 12 months as assessed by the CEC were reported. | As treated analysis set included all randomized participants in the study who received study treatment. | Posted | Count of Participants | Participants | From randomization up to Months 6 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | 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. | ITT analysis set included all enrolled participants who were randomized in the study. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Number | Percentage of participants | From randomization up to Months 3, 6, and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Shift From Baseline in Mini-Mental State Exam (MMSE) Score at 6 Months | 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. | As Treated (AT) analysis set included all participants randomized in the study who received study treatment and were analyzed by actual treatment received. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and n (number analyzed) signifies number of participants analyzed for specified categories. | Posted | Count of Participants | Participants | Baseline, 6 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Shift From Baseline in Markwalder Neurological Grading Scale (MGS) at 3, 6, and 12 Months | 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. | As treated analysis set included all randomized participants in the study who received study treatment. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Count of Participants | Participants | Baseline, Months 3, 6 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hospital Days and Intensive Care Unit (ICU) Days | 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. | Per Protocol (PP) analysis set was a subset of the ITT analysis set excluding participants with significant eligibility deviations, those who did not receive treatment as assigned, and those with other major protocol deviations (PD). This outcome measure was planned to be analyzed for specified arms only. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Median | Full Range | Days | From randomization up to 6 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in EuroQol-5 Dimension-5 Levels (EQ-5D-5L) Score at 6 Months | 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. | Per Protocol (PP) analysis set that consisted of a subset of the ITT analysis set excluding participants with significant eligibility deviations, those who did not receive treatment as assigned, and those with other major protocol deviations (PD). Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Score on scale | Baseline, Month 6 |
|
From randomization up to end of study (Up to 12 months [+/- 2 months])
All-cause mortality: All randomized participants. Serious and Other AEs: Treated analysis set included all randomized participants in the study who received study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgical Cohort: Surgery + Middle Meningeal Artery Embolization (eMMA) | Participants who underwent a surgical procedure as standard of care (SOC) for chronic subdural hematoma (cSDH) decompression were randomized to eMMA. eMMA was performed using TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (TRUFILL n-BCA) within 10 days after the surgery. | 4 | 133 | 44 | 130 | 39 | 130 |
| EG001 | Surgical Cohort: Standard of Care: Surgery Only | Participants who underwent a surgical procedure as SOC for cSDH decompression were randomized with no further intervention. | 11 | 132 | 52 | 133 | 33 | 133 |
| EG002 | Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA | Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. | 9 | 55 | 27 | 51 | 19 | 51 |
| EG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. | 7 | 56 | 19 | 57 | 18 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Focal dyscognitive seizures | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Cerebral arteriosclerosis | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| VIth nerve paralysis | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Lacunar stroke | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Gastrostomy tube site complication | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Subdural abscess | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Abdominal incarcerated hernia | Gastrointestinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA24 | Non-systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA24 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA24 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA24 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA24 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA24 | Non-systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA24 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA24 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA24 | Non-systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA24 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA24 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA24 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA24 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA24 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA24 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA24 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA24 | Non-systematic Assessment |
| |
| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA24 | Non-systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA24 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA24 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA24 | Non-systematic Assessment |
| |
| Adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA24 | Non-systematic Assessment |
| |
| Insulinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA24 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Diabetes insipidus | Endocrine disorders | MedDRA24 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA24 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA24 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA24 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA24 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA24 | Non-systematic Assessment |
| |
| Adult failure to thrive | Metabolism and nutrition disorders | MedDRA24 | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA24 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA24 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA24 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA24 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA24 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA24 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA24 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA24 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA24 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA24 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA24 | Non-systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA24 | Non-systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA24 | Non-systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA24 | Non-systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA24 | Non-systematic Assessment |
| |
| Thyroid cyst | Endocrine disorders | MedDRA24 | Non-systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA24 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA24 | Non-systematic Assessment |
| |
| Metastases to adrenals | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA24 | Non-systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA24 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA24 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA24 | Non-systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA24 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA24 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA24 | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Gastritis alcoholic | Gastrointestinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA24 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Necrotising soft tissue infection | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Mitral valve disease | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA24 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA24 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA24 | Non-systematic Assessment |
| |
| Physical deconditioning | General disorders | MedDRA24 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA24 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA24 | Non-systematic Assessment |
|
Study occurred during the Coronavirus Disease 2019 (COVID-19) pandemic, affecting participants' health and follow-up visits. The wide age range (up to 90 years) made follow-up difficult, especially for older participants reluctant to travel for Computed Tomography (CT) scans. Clinical effectiveness measures (e.g., modified Rankin Score) in chronic subdural hematoma (cSDH) were often suboptimal, but still reported. There was a lack of consensus on non-surgical management and medication regimens.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Johnson & Johnson MedTech | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2024 | Mar 25, 2026 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Not Reported |
|
| Other |
|
| Not Hispanic or Latino |
|
| Not Reported |
|
| Score on scale: 1 |
|
| Score on scale: 2 |
|
| Score on scale: 3 |
|
| Score on scale: 1 |
|
| Score on scale: 2 |
|
| Score on scale: Unknown |
|
| OG002 | Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA | Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
| OG001 | Surgical Cohort: Standard of Care: Surgery Only | Participants who underwent a surgical procedure as SOC for cSDH decompression were randomized with no further intervention. |
| OG002 | Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA | Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
|
| OG001 | Surgical Cohort: Standard of Care: Surgery Only | Participants who underwent a surgical procedure as SOC for cSDH decompression were randomized with no further intervention. |
| OG002 | Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA | Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
| OG001 | Surgical Cohort: Standard of Care: Surgery Only | Participants who underwent a surgical procedure as SOC for cSDH decompression were randomized with no further intervention. |
| OG002 | Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA | Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
| OG002 |
| Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA |
Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
| OG002 | Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA | Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
| Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA |
Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
| OG001 | Surgical Cohort: Standard of Care: Surgery Only | Participants who underwent a surgical procedure as SOC for cSDH decompression were randomized with no further intervention. |
| OG002 | Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA | Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
| Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA |
Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
Participants who underwent a surgical procedure as SOC for cSDH decompression were randomized with no further intervention. |
| OG002 | Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA | Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
| OG001 | Surgical Cohort: Standard of Care: Surgery Only | Participants who underwent a surgical procedure as SOC for cSDH decompression were randomized with no further intervention. |
| OG002 | Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA | Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Surgical Cohort: Standard of Care: Surgery Only |
Participants who underwent a surgical procedure as SOC for cSDH decompression were randomized with no further intervention. |
| OG002 | Experimental Non-surgical Cohort: Non-Surgical Medical Management (NSMM) + eMMA | Participants who received NSMM as SOC for cSDH decompression were randomized to eMMA. eMMA was performed using TRUFILL n-BCA up to 10 days after randomization. |
| OG003 | Non-surgical Cohort: Standard of Care: NSMM Alone | Participants who received NSMM as SOC for cSDH decompression were randomized and continue to receive NSMM. |
|
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