A Single Center Randomized Control Trial to Evaluate the Efficacy of Middle Meningeal Artery Embolization in the Treatment of Chronic Subdural Hematomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Radiographic resolution of hematoma
研究概览
简要总结
Chronic subdural hematomas (cSDH) are one form of bleeding in the head. They are one of the most common diseases encountered by neurosurgeons across the country. The cSDH can push on the brain and produce symptoms that include seizures, weakness, loss of sensation, and confusion. Many of these cSDH produce repetitive bleeding.
Treatment has largely consisted of surgical drainage of hematoma (also known as a blood clot) through either a small hole in the skull or open surgery. However, it is common for the cSDH to reappear despite these procedures. A recent study has shown a treatment failure rate of 27% and a need for additional surgery at 19%.
A new approach to treatment of cSDH blocks the blood supply to the tissue that produces the repeated bleeding. Catheters are used to gain access to the middle meningeal artery (MMA), an artery that supplies the coverings of the brain. The artery is blocked using small particles or glue in a process called embolization. A recent pilot study of 72 patients who underwent MMA embolization showed a much lower rate of repeated bleeding. Based on these results, it is thought that this procedure holds promise in reducing the number of cSDH that require one or more operations. The goal of this study is to systematically examine if blocking the blood supply to the tissue responsible for repeated bleeding helps the cSDH resolve and improves patient outcomes.
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
- 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
- •18 years of age or older
- •Have radiographic imaging showing a cSDH > 7mm in maximal thickness encompassing > 50% of the convexity (non-focal).
- •Capable of giving consent for the procedure or have an acceptable surrogate capable of giving consent on the subject's behalf
排除标准
- •The cSDH is secondary to an underlying vascular malformation, tumor, cyst, spontaneous cerebrospinal fluid hypotension or previous craniotomy
- •Life expectancy < 6 months
- •Vascular anatomy that puts the patient at high risk for adverse events (e.g. critical carotid stenosis, abnormal external-internal carotid circulation)
- •Incapable of being reasonably expected to be able to attend follow-up appointments at Dartmouth-Hitchcock Medical Center
- •Vulnerable patients including homeless patients, incarcerated patients and mentally ill patients without appropriate medical decision-making proxy that the physician believes are incapable of appropriately assessing the risks of the procedure
研究组 & 干预措施
Symptomatic, standard of care
Patients in this group will be offered all procedures and care deemed appropriate by the Neurosurgeon in charge of their care. This could include surgical intervention, observation, medical management.
干预措施: Standard of care including possible surgical evacuation of subdural hematoma (Procedure)
Symptomatic, MMA embolization + standard of care
Patients in this group will be treated with the standard of care treatment (the same care described in the arm "Symptomatic, standard of care") but will also undergo MMA embolization of the affected side(s).
干预措施: Embolization of the Middle Meningeal Artery (Procedure)
Symptomatic, MMA embolization + standard of care
Patients in this group will be treated with the standard of care treatment (the same care described in the arm "Symptomatic, standard of care") but will also undergo MMA embolization of the affected side(s).
干预措施: Standard of care including possible surgical evacuation of subdural hematoma (Procedure)
Asymptomatic, standard of care
Patients in this group will be offered all procedures deemed appropriate by the Neurosurgeon in charge of their care. This could include surgical intervention, observation, medical management.
干预措施: Standard of care including possible surgical evacuation of subdural hematoma (Procedure)
Asymptomatic, standard of care + MMA embolization
Patients in this group will be treated with the standard of care treatment (the same care described in the arm "Asymptomatic, standard of care") but will also undergo MMA embolization of the affected side(s).
干预措施: Embolization of the Middle Meningeal Artery (Procedure)
Asymptomatic, standard of care + MMA embolization
Patients in this group will be treated with the standard of care treatment (the same care described in the arm "Asymptomatic, standard of care") but will also undergo MMA embolization of the affected side(s).
干预措施: Standard of care including possible surgical evacuation of subdural hematoma (Procedure)
结局指标
主要结局
Radiographic resolution of hematoma
时间窗: 12 months post-procedure
CT scan to evaluate for residual hematoma, comparing baseline to 12 months. Can be canceled if cSDH is completely resolved at 3 or 6 months
Radiographic resolution of hematoma
时间窗: 3 months post-procedure
CT scan to evaluate for residual hematoma, comparing baseline to 3 months
Radiographic resolution of hematoma
时间窗: 6 months post-procedure
CT scan to evaluate for residual hematoma, comparing baseline to 6 months. Can be canceled if cSDH is completely resolved at 3 months
次要结局
- NIH Stroke Scale(6 months)
- Symptomatic improvement(12 month follow up appointment)
- Symptomatic improvement(3 month follow up appointment)
- Symptomatic improvement(6 month follow up appointment)
- NIH Stroke Scale(3 months)
研究者
Clifford J. Eskey
Director, Interventional Neuroradiology
Dartmouth-Hitchcock Medical Center