Embolization of Middle Meningeal Artery for Subdural Hematoma in Canada -EMMA-Can
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Radiographic recurrence
研究概览
简要总结
EMMA-Can is a prospective cohort study to assess the safety and effectiveness of MMA-embolization for the treatment of CSDH.
Hypothesis- EMMA reduces the recurrence rate of CSDH with or without concomitant surgical evacuation.
详细描述
The purpose of our study is to conduct a prospective cohort study to assess the safety and effectiveness of MMA embolization for the treatment of CSDH. All patients with CSDH presenting to the emergency room or to neurosurgical outpatient clinic will be screened for potential enrollment. If the subject is willing to participate an informed consent will be obtained.
All patients presenting to the emergency room or in neurosurgery clinic with CSDH diagnosed on CT scan will be considered for the study. If the patient needs emergent evacuation for clinical reasons, patient will be taken for surgical evacuation before consideration of EMMA. Patients that are more likely to have recurrence after surgical evacuation are those with recurrent CSDH, on antiplatelet or antithrombotic treatment. The EMMA could be used as primary treatment or in conjunction with surgery in these patients or in patients who may not be good surgical candidate.
Follow up - All patients will be followed after discharge from the hospital at 1, 3, 6 and 12 months interval. The follow up at 3 months will include plain CT head of the patient, which is standard of care for most patients. The follow up at 6 and 12 months will be only clinical follow up.
Patients will be assessed for recurrence of CSDH on CT scan of head. Symptoms associated with the recurrence will be recorded. The size of the CSDH will be measured and compared to previous scans and peri-procedural morbidity and mortality related to EMMA will be sought. This will be done at 3 months post EMMA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •- All patients with subdural hematoma coming to the emergency room or to neurosurgical outpatient clinic.
排除标准
- •If informed consent cannot be obtained from the patient or their substitute decision maker.
- •Known allergy to liquid embolic agent
研究组 & 干预措施
Embolization of Middle Meningeal Artery for Subdural Hematoma
All patients with CSDH will undergo embolization of Middle Meningeal artery
干预措施: Embolization of the middle meningeal artery (Procedure)
结局指标
主要结局
Radiographic recurrence
时间窗: up to 90-days for EMMA
Recurrence of CSDH on imaging (CT scan or MRI) of head .
Symptomatic recurrence
时间窗: up to 90-days from EMMA
Symptomatic recurrence attributable to the side of the CSDH on imaging (CT scan or MRI) of head
次要结局
- Size(30 days and 90 days)
- Mortality within 90-days(up to 90-days)
- 90 day Modified Rankin Score </=3(90-days)
- Reduction of CSDH size at 90-days(90-days)
- Morbidity within 90-days(up to 90-days)
- 90-day MOCA and EQ-5D-5L health score(Day 90)
- Discharge destination(up to 100 weeks)
- Length of hospital stay(up to 100 weeks)
研究者
Jai Shankar
Professor
University of Manitoba