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Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma (EMMA-CS)

2026年11月4日 更新者：University Hospital Hradec Kralove

Prospective Multicentric Study of Middle Meningeal Artery Embolisation Combined With Surgical Treatment for Chronic Subdural Hematoma

This international multicenter study evaluates the efficacy and safety of middle meningeal artery embolization (MMAE) using PVA particles or liquid embolic agents as a perioperative treatment to prevent the recurrence of chronic subdural hematoma (cSDH). All participating patients across centers in the Czech Republic and Slovakia will receive the minimally invasive MMAE procedure within 7 days prior to or after surgical evacuation, with the primary goal of assessing hematoma recurrence rates and procedure-related complications over a 90-day follow-up period.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

200

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。

学习联系方式

研究联系人备份

学习地点

  • 捷克语
      • Hradec Králové、捷克语、500 05
        • 招聘中
        • University Hospital Hradec Kralove
        • 接触：
      • Liberec、捷克语
        • 招聘中
        • Hospital Liberec
        • 接触：
        • 接触：
          • Miroslav Sercl
      • Olomouc、捷克语、77909
      • Prague、捷克语、16902
        • 招聘中
        • The Military University Hospital Prague
        • 接触：
      • Prague、捷克语
      • České Budějovice、捷克语

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 及以上 (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:

  • Age 18 years or older.
  • Diagnosis of a symptomatic or asymptomatic chronic or subacute subdural hematoma (cSDH) confirmed by neuroimaging (CT or MRI).
  • Hematoma thickness of 5 mm or greater at its widest point on baseline neuroimaging.
  • Patient is managed either conservatively or via standard surgical evacuation (e.g., burr-hole craniostomy) where MMAE is planned as a standalone or adjunctive treatment.
  • Written informed consent provided by the patient or a legally authorized representative.

Exclusion Criteria:

  • Acute subdural hematoma requiring emergency surgical decompression due to severe neurological deficit with signs of impending herniation.
  • Evidence of an active intracranial infection or sepsis.
  • Known vascular malformation, aneurysm, or dural arteriovenous fistula as the source of the hematoma.
  • Severe uncorrectable coagulopathy or bleeding disorder (e.g., platelet count <50,000/µL or INR >2.0 that cannot be safely corrected before the procedure).
  • Severe renal impairment (e.g., eGFR <30 mL/min/1.73m²) or known severe allergy to iodinated contrast media (unless adequate premedication is possible).
  • Life expectancy of less than 3 months due to severe comorbid conditions.

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：预防
  • 分配：非随机化
  • 介入模型：阶乘赋值
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention Arm

Patients with chronic subdural hematoma (cSDH) who undergo middle meningeal artery embolization (MMAE). This procedure is performed either as a standalone treatment or as an adjunct to surgical evacuation, based on clinical indication.
设备：Middle Meningeal Artery Embolisation

Endovascular occlusion of the middle meningeal artery (MMA) performed under fluoroscopic guidance. The procedure aims to devascularize the chronic subdural hematoma membrane to promote hematoma resorption and prevent recurrence.
无干预：Standard Care Arm

Patients with chronic subdural hematoma (cSDH) who receive standard clinical care without undergoing middle meningeal artery embolization. This includes standard surgical evacuation (burr-hole craniostomy) or conservative management (observation, medication) based on current guidelines.

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
Rate of hematoma recurrence or treatment failure requiring surgical evacuation
大体时间：Up to 90 days post-enrollment.

The proportion of participants who experience a symptomatic or radiologically confirmed recurrence or progression of chronic subdural hematoma (cSDH) in the target hemisphere that requires surgical intervention (or re-operation for surgically treated patients) within the follow-up period.
Up to 90 days post-enrollment.

次要结果测量

结果测量
措施说明
大体时间
Incidence of periprocedural and postprocedural complications
大体时间：During hospitalization, up to 7 days post-procedure

Safety outcomes evaluating complications related to the middle meningeal artery embolisation (MMAE) procedure or the embolic material. This includes technical failure, ischemic stroke, new intracranial hemorrhage, facial nerve palsy, visual impairment, local arterial access site complications (e.g., hematoma, pseudoaneurysm), or severe allergic reactions to contrast media.
During hospitalization, up to 7 days post-procedure

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

University Hospital Hradec Kralove

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)

2026年6月1日

初级完成 (估计的)

2029年4月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2026年8月3日

首先提交符合 QC 标准的

2026年8月3日

首次发布 (实际的)

2026年8月7日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年6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

  • FN HK
  • Internal academic grant (其他标识符：University Hospital Hradec Kralove, Czech Republic)

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

De-identified individual participant data (IPD) including baseline demographics, clinical characteristics, neuroimaging metrics (hematoma thickness and volume), procedural details of middle meningeal artery embolisation, and follow-up clinical and radiological outcomes will be shared. Only data that underlie the results reported in the final published article will be made available.

IPD 共享时间框架

Data will become available beginning 6 months after the primary publication of the study results and will remain accessible for 36 months following publication.

IPD 共享访问标准

Anonymized data will be shared with qualified academic researchers upon reasonable request. Requests must include a scientifically sound research proposal and a statistical analysis plan. Proposals will be reviewed and approved by the principal investigators of the study. Data will be shared strictly for the purpose of meta-analysis or independent verification of the results via secure data transfer.

IPD 共享支持信息类型

  • 研究方案
  • 树液

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

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.

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