Middle Meningeal Artery Embolization With Liquid Embolic Agent for Treatment of Chronic Subdural Hematoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of CSDH regression
研究概览
简要总结
The study evaluates the clinical and imaging outcome of middle meningeal artery (MMA) embolization with liquid embolic agent for treatment of chronic subdural hematoma (CSDH)
详细描述
This study is a prospective one arm trial designed to assess the safety and efficacy of MMA embolization with liquid embolic agents (onyx/squid/Phil) as the main treatment of CSDH.
The subjects are enrolled in the study according to inclusion and exclusion criteria. Imaging and clinical presentations of patients are recorded. Within 48 hours of embolization, patients are assessed with clinical examination and with a brain CT scan to evaluate in any change in their symptoms and CSDH volume. 2-4 weeks after embolization, patients are evaluated in clinic for any change in their symptoms and signs. 60 days after embolization patients are examined clinically and are assessed for SDH volume change in CT scan and MRI.
If there is any significant increase in CSDH volume or any deterioration of patient, evacuation of hematoma is considered.
MMA embolization is performed under general anesthesia using biplane or monoplane angiography. Femoral or radial accesses are used. Guiding catheter is advanced into external carotid artery in corresponding side. The corresponding MMA is catheterized distally by micro-catheter and is embolized by liquid embolic agents. Patients are discharge next day if they are stable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •patients diagnosed chronic or subacute subdural hematoma
- •Patients had symptoms/signs associated with chronic or subacute subdural hematoma: severe headache, hemiparesis/monoparesis, dementia, aphasia/dysphasia, loss of consciousness, ...
- •Asymptomatic large chronic/subacute hematoma after 6-8 weeks of failed conservative treatment
排除标准
- •presentation with coma (GCS =< 8)
- •patients needs emergent evacuation of hematoma,
- •patients could not participate in 60 days follow-up
- •pregnant patients
- •acute subdural hematoma
- •contraindication to contrast
- •contradiction to angiography
- •difficult access to MMA due to anatomical variation
- •contraindication to liquid embolic agent
- •unmanaged/uncontrollable bleeding disorders
结局指标
主要结局
Incidence of CSDH regression
时间窗: 60 dyas
Volume reduction of CSDH in follow-up imaging (CT/MRI) 60 days after embolization
次要结局
- Incidence of CSDH progression or recurrence(60 days)
- Incidence of new neurological deficit (ND)(60 days)
- Incidence of new ischemic stroke(60 days)
- incidence of Death(60 days)
- Incidence of myocardial infarction/myocardial ischemia(60 days)
- Incidence of embolization complication in brain(48 hours)
- incidence of embolization complication out of brain(15 days)
研究者
Humain Baharvahdat
Associate Professor
Mashhad University of Medical Sciences