Outcomes of Middle Meningeal Artery for Treatment of Chronic Subdural Hematoma; Middle Meningeal Artery Embolization for Chronic Subdural Hematoma (MESH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 19
- 主要终点
- Rescue surgical evacuation
研究概览
简要总结
This multi-center retrospective cohort study aims to investigate the real-world outcomes of chronic subdural hematoma treated with MMAE, including clinical effectiveness, recurrence rates, and safety profile.
详细描述
Chronic subdural hematoma (cSDH) is a prevalent neurosurgical condition marked by the accumulation of blood in the subarachnoid space. Primarily affecting elderly individuals, cSDH is associated with significant morbidity and mortality rates. Current standard treatments for cSDH involve surgical evacuation through burr hole craniotomy or twist-drill craniotomy; however, recent research has illuminated the potential significance of the middle meningeal artery (MMA) in cSDH pathogenesis, suggesting an innovative minimally invasive treatment avenue. The investigator team is attempting to determine whether MMA embolization has demonstrated a favorable safety profile with a low incidence of treatment-related complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Consecutive adult patients (18 yrs. of age or older)
- •Endovascular embolization of middle meningeal artery using any embolization material:
- •PVA particles; Onyx, nBCA glue; dimethyl sulfoxide, microcoils, PVA with microcoils
排除标准
- •Endovascular embolization of middle meningeal artery using any other embolization material
结局指标
主要结局
Rescue surgical evacuation
时间窗: Between 1-3 months post MMAE
The percentage of patients who were determined to require rescue surgical evacuation of their hematoma will be tabulated and reported
Reaccumulation of Hematoma
时间窗: Within 1 month post MMAE
The percentage of patients who were determined to have a reaccumulation of their hematoma will be tabulated and reported
次要结局
- Reaccumulation of Hematoma(Between 12-24 months post MMAE)
- Clinical Outcome at Follow-up Clinical outcome at follow-up(Between 12-24 months post MMAE)
- Timing of Complications(Following the procedure, up to 4 weeks)
- Clinical outcome at discharge(Upon study discharge, up to 24 months)
- Disposition After Discharge(Upon study discharge, up to 24 months)
- Rescue surgical evacuation(Between 3-12 months post MMAE)
- Complications following MMAE(Following the procedure, up to 4 weeks)
- Relatedness of Complications(Following the procedure, up to 4 weeks)
- Duration of Hospital Stay(Upon study discharge, up to 24 months)
- Reaccumulation of Hematoma(Between 1-3 months post MMAE)
- Reaccumulation of Hematoma(Between 3-6 months post MMAE)
- Reaccumulation of Hematoma(Between 6-12 months post MMAE)
- Clinical Outcome at Follow-up Clinical outcome at follow-up(Upon study discharge, 1-4 weeks)
- Clinical Outcome at Follow-up Clinical outcome at follow-up(Within 1 month post MMAE)
- Clinical Outcome at Follow-up Clinical outcome at follow-up(Between 1-3 months post MMAE)
- Clinical Outcome at Follow-up Clinical outcome at follow-up(Between 3-6 months post MMAE)
- Clinical Outcome at Follow-up Clinical outcome at follow-up(Between 6-12 months post MMAE)