Prospective Multicentric Study of Middle Meningeal Artery Embolisation Combined With Surgical Treatment for Chronic Subdural Hematoma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Rate of hematoma recurrence or treatment failure requiring surgical evacuation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Middle Meningeal Artery Embolisation (Device)
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.
结局指标
主要结局
Rate of hematoma recurrence or treatment failure requiring surgical evacuation
时间窗: 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.
次要结局
- Incidence of periprocedural and postprocedural complications(During hospitalization, up to 7 days post-procedure)