Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- The proportion of patients who require craniotomy due to the progression of epidural hematoma 7 days after injury*, and neurogenic death 28 days after injury
研究概览
简要总结
A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
详细描述
This study is a prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
All patients diagnosed with acute epidural hematoma through cranial CT will undergo neurological examination and measurement of hematoma size. For patients who meet the inclusion criteria, they will be randomly assigned 1:1 to the middle meningeal artery embolization group (intervention group) and the conservative treatment group (control group). A total of 194 subjects need to be enrolled, including 97 in the intervention group and 97 in the control group.
Primary Outcome： The proportion of patients who require craniotomy due to the progression of epidural hematoma 7 days after injury*, and neurogenic death 28 days after injury.
*This includes patients who have actually undergone surgery and those who were deemed necessary by the committee but did not undergo surgery for various reasons.
Secondary outcome：
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention group
MMA embolization
干预措施: MMA embolization plus medical therapy (Procedure)
Control group
Conservative treatment
干预措施: Medical therapy alone (Drug)
结局指标
主要结局
The proportion of patients who require craniotomy due to the progression of epidural hematoma 7 days after injury*, and neurogenic death 28 days after injury
时间窗: Within 28 days after injury
\*This includes patients who have actually undergone surgery and those who were deemed necessary by the committee but did not undergo surgery for various reasons.
次要结局
- Changes in hematoma volume 7±2 days after injury (or at discharge)(7±2 days after injury (or at discharge))
- GCS score at 7±2 days after injury (or at discharge)(7±2 days after injury (or at discharge))
- Hematoma volume 28±7 days after injury(28±7 days after injury)
- GCS score at 28±2 days after injury(28±2 days after injury)
- ICU hospitalization days(28±2 days after injury)
- Total hospitalization days(28±2 days after injury)
- Discharge rehabilitation destination (home vs rehabilitation hospital)(28±2 days after injury)
- Number of re-hospitalizations(6 months after injury)
- GOSE score at 3 months after injury(3 months after injury)
- EQ-5D scale scores at 3 months after injury(3 months after injury)
- GOSE score at 6 months after injury(6 months after injury)
- EQ-5D scale scores at 6 months after injury(6 months after injury)