Pilot Study to Evaluate Safety of and Efficacy of Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in size of SDH
研究概览
简要总结
Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). Although MMA embolization is minimally-invasive procedure that is routinely used for the treatment of tumors or vascular formations (1), this study investigates the use of an established procedure for a new disease state.
详细描述
The purpose of the research study is to evaluate the safety and efficacy of a new, less-invasive procedure to treat chronic subdural hematoma (cSDH). A subdural hematoma occurs when blood collects on the brain's surface beneath the skull. Subdural hematomas can be life-threatening. They usually result from a head injury. This study will compare the new procedure to conventional surgical treatment of chronic subdural hematoma (cSDH). The new procedure is called middle meningeal artery embolization (MMA).
Current or conventional treatment of chronic subdural hematoma (cSDH) involves surgery (burr hole drainage and craniotomy) to access and remove the cause of the bleeding that is causing the subdural hematoma.
The new procedure, MMA embolization, involves guiding a catheter that is inserted into a blood vessel to the area of the brain that is supplying blood to the subdural hematoma. Particles or a special type of glue will be released to stop the bleeding that is causing the subdural hematoma. This technique has been used to treat other brain conditions, for example, (to treat tumors or malformation of blood vessels).
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
- •Age 18 or older
- •Participant or Surrogate must be English speaking
- •Subjects must have a diagnosis of chronic or acute-on subdural hematoma based on brain imaging, as documented by an
- •One or more symptoms attributable to chronic SDH including headache cognitive impairment, gait instability, seizure, or mild focal neurologic deficit.
- •In opinion of Investigator or the subject's referring physician, the subject has failed conservative management.
排除标准
- •The Subdural hematoma is causing mass effect significant enough to cause marked or progressive neurologic impairment
- •Any requirement for urgent surgical evacuation is necessary
- •Life expectancy is less than 6 months in the opinion of the subject's primary physician
- •Markedly tortuous vasculature precluding safe endovascular access, as assessed on angiogram
- •Acute subdural hematomas
- •Health insurance doesn't cover MMA embolization or performing Surgeon and follow up visits are considered out of network.
- •Pregnancy
研究组 & 干预措施
Middle Meningeal Artery Embolization
Middle Meningeal Artery Embolization
干预措施: Middle Meningeal Artery procedure (Procedure)
Traditional Surgery
Craniotomy/Burr hole
干预措施: Traditional Surgery (Procedure)
结局指标
主要结局
Change in size of SDH
时间窗: 6 months
Changes in size of SDH will be recorded in maximum diameter within 6 months.
次要结局
- Change in Neurological status(6 months)
研究者
Ronald Benitez, MD
Director of Endovascular Surgery
Atlantic Health System