使用 TRUFILL® n-BCA 进行脑膜中动脉栓塞治疗硬膜下血肿 (MEMBRANE)
2026年8月27日 更新者：Cerenovus, Part of DePuy Synthes Products, Inc.
这是一项前瞻性、多中心、开放标签、随机对照研究，受试者可以单独接受标准治疗 (SOC) 或接受 SOC 和 TRUFILL n-BCA MMA 栓塞治疗慢性硬膜下血肿 (cSDH)。
研究概览
地位
完全的
条件
详细说明
这是一项前瞻性、多中心、开放标签、随机对照研究，其中多达 376 名受试者将被随机分配接受单独的标准护理 (SOC) 或 SOC 和 TRUFILL n-BCA MMA 栓塞治疗 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
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Nanjing、中国、210008
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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Shanghai、中国、200127
- Renji Hospital, Shanghai Jiaotong University School of Medicine
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
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Arizona
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Tucson、Arizona、美国、85710
- Carondelet St Joseph's Hospital
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California
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Walnut Creek、California、美国、94598
- John Muir Physician Network Clinical Research Center
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Colorado
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Englewood、Colorado、美国、80113
- Swedish Medical Center
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Connecticut
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Hartford、Connecticut、美国、06032
- Hartford Hospital
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New Haven、Connecticut、美国、06510
- Yale University
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District of Columbia
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Washington D.C.、District of Columbia、美国、20037
- George Washington University
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Florida
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Jacksonville、Florida、美国、32207
- Baptist Medical Center
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Miami、Florida、美国、33136
- University of Miami - Jackson Memorial Hospital
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Orlando、Florida、美国、32803
- Advent Health Orlando
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Georgia
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Atlanta、Georgia、美国、30309
- Piedmont Hospital
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Marietta、Georgia、美国、30067
- Wellstar Health System
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Savannah、Georgia、美国、31405
- Memorial Health University Health Center
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland
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Massachusetts
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Burlington、Massachusetts、美国、02115
- Lahey Hospital & Medical Center
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Minnesota
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Minneapolis、Minnesota、美国、55455
- University of Minnesota
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New York
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New York、New York、美国、10029
- Mount Sinai Hospital
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Valhalla、New York、美国、10595
- Westchester Medical Center
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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Ohio
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Cincinnati、Ohio、美国、45267
- University of Cincinnati
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Columbus、Ohio、美国、43214
- Ohio Health
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Toledo、Ohio、美国、43608
- Mercy Health St Vincent Medical Center
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health and Science University
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Hospital of the University of Pennsylvania
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Pittsburgh、Pennsylvania、美国、15212
- Allegheny General Hospital of Research
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Tennessee
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Memphis、Tennessee、美国、38120
- Semmes Murphey Foundation
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Nashville、Tennessee、美国、37232
- Vanderbilt University Medical Center
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Texas
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Plano、Texas、美国、75075
- Texas Stroke Institute
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Utah
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Salt Lake City、Utah、美国、84132
- University of Utah
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Virginia
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Charlottesville、Virginia、美国、22908
- University of Virginia School of Medicine
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West Virginia
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Morgantown、West Virginia、美国、26506
- West Virginia Hospital
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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
描述
纳入标准：
- 随机化前 mRS </= 3
- 慢性硬膜下血肿确诊
- 完成知情同意
排除标准：
- 急性硬膜下血肿
- 目标硬膜下血肿的既往治疗
- Markwalder 评估 >/= 3
- 格拉斯哥昏迷量表 < 9
- 推测的微生物重复感染
- 颅内肿瘤或占位性病变的CT或MRI证据
- 预期寿命 < 1 年
- 怀孕、哺乳或处于育龄期并计划在研究期间怀孕的女性
- 目前参与另一项可能混淆研究终点的临床试验
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 |
|---|---|
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实验性的：实验：介入队列：治疗组
标准护理手术 + 栓塞术
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护理手术 +栓塞
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有源比较器：仅护理标准
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仅护理标准
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实验性的：介入队列：治疗臂
护理标准医疗管理 +栓塞
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护理标准医疗管理 +栓塞
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有源比较器：仅护理医疗管理标准
医疗管理标准。
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仅护理医疗管理标准
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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 |
|---|---|---|
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由独立核心实验室评估的慢性硬膜下血肿（cSDH）残留或再积聚（大于[>] 10毫米[mm]）或6个月时对cSDH的任何再手术或外科手术
大体时间：6个月后
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展示了在治疗中使用eMMA与标准护理相比，由独立核心实验室评估的6个月时cSDH残留或再积聚（>10毫米）的参与者百分比和比值比（OR），或随机分组后6个月内对cSDH进行再次手术或外科手术的情况。
cSDH残留或再积聚>10毫米是手术清除指南中包含的阈值，并且考虑到其与死亡率、生活质量下降以及新手术或重复手术并发症的关联，被认为具有预后重要性。
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6个月后
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出现所有不良事件（AEs）的参与者百分比
大体时间：从随机化开始至6个月
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不良事件是指研究期间参与者发生的任何不良医疗经历（体征、症状、疾病、异常实验室值或其他医疗事件），无论是否与试验器械相关。
严重不良事件是指任何导致以下结果的不良事件：死亡、持续或显著的残疾/失能、需要住院治疗或延长现有住院时间、危及生命的经历、先天性异常/出生缺陷，并可能危及参与者和/或可能需要医疗或手术干预以防止发生上述任一结果。
所有不良事件，包括严重和非严重不良事件，均已报告。
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从随机化开始至6个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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3个月时获得良好功能结局的参与者人数（改良Rankin评分[mRS]为0-2分，或基线mRS大于等于[>=]3分时未出现恶化）
大体时间：在第3个月
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如果3个月mRS评分小于等于（<=）2，或者如果基线mRS评分≥3时未出现恶化，则认为参与者具有良好的功能结局。
mRS用于评估中风或其他神经系统疾病导致残疾患者在日常生活活动中的残疾或依赖程度。
量表范围为0-6，具体如下：0 = 无症状；1 = 无明显残疾。
尽管有症状，仍能进行所有日常活动；2 = 轻度残疾。
无需协助可处理个人事务，但无法进行所有既往活动；3 = 中度残疾。
需要部分帮助，但能独立行走；4 = 中重度残疾。
无协助无法自理个人需求，且无法独立行走；5 = 重度残疾。
需要持续护理和关注，卧床不起，大小便失禁；6 = 死亡；数值越高反映残疾程度越严重或死亡。
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在第3个月
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6个月时迷你精神状态检查（MMSE）评分较基线发生变化的受试者人数
大体时间：基线，6个月
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MMSE是评估老年患者精神状态的标准化工具。
它包括定向力、注意力、记忆力、语言能力和视觉空间技能的测试。
它由问题（例如“今年是哪一年？”）和任务（例如“随意构思并写下一个句子”）组成。
MMSE评分范围为0到30分。
0-17分表示严重认知障碍，18-23分表示轻度障碍，24-30分被视为正常。
分数越高表明认知功能越好。
基线定义为随机化前收集的最后一个非缺失测量值。
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基线，6个月
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住院天数和重症监护病房（ICU）天数
大体时间：从随机分组起至6个月
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住院天数包括索引手术的总住院时间（含ICU）。
ICU天数包括索引手术住院期间在ICU的住院时间。
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从随机分组起至6个月
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6个月时欧洲五维健康量表-5级（EQ-5D-5L）评分相对于基线的变化
大体时间：基线，第6个月
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EQ-5D-5L 基于五个类别测量自评的健康相关生活质量：行动能力、自我照顾、日常活动、疼痛/不适以及焦虑/抑郁。
每个类别均按描述该领域问题严重程度的量表进行评分（即，“我行走无困难”、“轻微困难”、“中度困难”、“严重困难”或“无法行走”）。
该工具还包含一个整体健康量表，范围从1到100，用于描述他们的健康状况，100代表可想象的最佳状态。
分数越高表明生活质量越好。
基线定义为随机化前收集的最后一个非缺失测量值。
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基线，第6个月
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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
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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.
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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
大体时间：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.
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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
大体时间：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.
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At Months 3, 6 and 12
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Median Time to Achieve Complete Resolution of the cSDH
大体时间：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.
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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
大体时间：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.
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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
大体时间：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.
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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
大体时间：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.
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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
大体时间：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.
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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
大体时间：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.
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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)
大体时间：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.
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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)
大体时间：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.
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From randomization up to Months 3, 6, and 12
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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
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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.
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Baseline, Months 3, 6 and 12
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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卫生经济学
大体时间：手术后 365 天
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住院天数
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手术后 365 天
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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。
调查人员
- 首席研究员：Christopher Kellner, MD、Mount Sinai Hospital
- 首席研究员：Ansaar Rai, MD、West Virginia University
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
- 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.
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8月28日
上次提交的符合 QC 标准的更新
2026年8月27日
最后验证
2026年8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
强生医疗器械公司与耶鲁开放数据访问 (YODA) 项目达成协议，作为独立审查小组评估研究人员和医生对临床研究报告和参与者水平数据的请求，以推进医学知识的科学研究和公共卫生。
访问研究数据的请求可以通过 YODA 项目网站提交，网址为 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
在美国制造并从美国出口的产品
不
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.