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使用 TRUFILL® n-BCA 进行脑膜中动脉栓塞治疗硬膜下血肿 (MEMBRANE)

2026年11月2日 更新者：Cerenovus, Part of DePuy Synthes Products, Inc.

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).

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

376

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Nanjing、中国、210008
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
      • Shanghai、中国、200127
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • University of Alabama at Birmingham
    • Arizona
      • Tucson、Arizona、美国、85710
        • Carondelet St Joseph's Hospital
    • California
      • Walnut Creek、California、美国、94598
        • John Muir Physician Network Clinical Research Center
    • Colorado
      • Englewood、Colorado、美国、80113
        • Swedish Medical Center
    • Connecticut
      • Hartford、Connecticut、美国、06032
        • Hartford Hospital
      • New Haven、Connecticut、美国、06510
        • Yale University
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20037
        • George Washington University
    • Florida
      • Jacksonville、Florida、美国、32207
        • Baptist Medical Center
      • Miami、Florida、美国、33136
        • University of Miami - Jackson Memorial Hospital
      • Orlando、Florida、美国、32803
        • Advent Health Orlando
    • Georgia
      • Atlanta、Georgia、美国、30309
        • Piedmont Hospital
      • Marietta、Georgia、美国、30067
        • Wellstar Health System
      • Savannah、Georgia、美国、31405
        • Memorial Health University Health Center
    • Maryland
      • Baltimore、Maryland、美国、21201
        • University of Maryland
    • Massachusetts
      • Burlington、Massachusetts、美国、02115
        • Lahey Hospital & Medical Center
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota
    • New York
      • New York、New York、美国、10029
        • Mount Sinai Hospital
      • Valhalla、New York、美国、10595
        • Westchester Medical Center
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati、Ohio、美国、45267
        • University of Cincinnati
      • Columbus、Ohio、美国、43214
        • Ohio Health
      • Toledo、Ohio、美国、43608
        • Mercy Health St Vincent Medical Center
    • Oregon
      • Portland、Oregon、美国、97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • Hospital of the University of Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15212
        • Allegheny General Hospital of Research
    • Tennessee
      • Memphis、Tennessee、美国、38120
        • Semmes Murphey Foundation
      • Nashville、Tennessee、美国、37232
        • Vanderbilt University Medical Center
    • Texas
      • Plano、Texas、美国、75075
        • Texas Stroke Institute
    • Utah
      • Salt Lake City、Utah、美国、84132
        • University of Utah
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • University of Virginia School of Medicine
    • West Virginia
      • Morgantown、West Virginia、美国、26506
        • West Virginia Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 90年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Experimental: Interventional Cohort: Treatment Arm

Standard of Care Surgery + Embolization
设备：Experimental: Interventional Cohort: TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

Standard of Care Surgery + Embolization
有源比较器：Standard of Care Surgery Only

Standard of Care Surgery Only
其他：Standard of Care Surgery

Standard of Care Surgery Only
实验性的：Interventional Cohort: Treatment Arm

Standard of Care Medical Management + Embolization
设备：Experimental: Interventional Cohort: TRUFILL n-BCA Liquid Embolic System

Standard of Care Medical Management + Embolization
有源比较器：Standard of Care Medical Management Only

Standard of Care medical management only.
其他：Standard of Care Medical Management

Standard of Care Medical Management Only

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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)
大体时间：From randomization up to 6 months

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

次要结果测量

结果测量
措施说明
大体时间
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)
大体时间：At Month 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.
At Month 3
Change From Baseline in Hematoma Volume at 3, 6 and 12 Months, as Assessed by an Independent Core Laboratory
大体时间：Baseline, Months 3, 6 and 12

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
大体时间：Month 3, Month 6 and Month 12

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
大体时间：At Months 3, 6 and 12

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
大体时间：From baseline up to Month 12

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
大体时间：At Months 3, 6, and 12

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
大体时间：From randomization up to Months 3 and 6

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
大体时间：From randomization up to Months 3, 6 and 12

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
大体时间：From randomization up to Month 12

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
大体时间：Baseline, Months 3, 6 and 12

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)
大体时间：From randomization up to Months 6 and 12

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)
大体时间：From randomization up to Months 3, 6, and 12

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
大体时间：Baseline, 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
大体时间：Baseline, Months 3, 6 and 12

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
大体时间：From randomization up to 6 months

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
大体时间：Baseline, Month 6

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Cerenovus, Part of DePuy Synthes Products, Inc.

调查人员

  • 首席研究员：Ansaar Rai, MD、West Virginia University
  • 首席研究员：Christopher Kellner, MD、MOUNT SINAI HOSPITAL

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年5月27日

初级完成 (实际的)

2024年8月15日

研究完成 (实际的)

2025年3月26日

研究注册日期

首次提交

2021年3月23日

首先提交符合 QC 标准的

2021年3月23日

首次发布 (实际的)

2021年3月25日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CNV_2020_01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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