Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- cSDH recurrence rates after surgery
研究概览
简要总结
Patients with a chronic subdural hematoma (cSDH), that is, a blood accumulation between two meninges developing over a long period of time, often have recurrent bleedings after an initial operation. The study aims to show that additional surgery reduces the risk of recurrent bleeding.
The additional procedure aims to block small blood vessels in the skull with tiny plastic particles. The small blood vessels are embolized using X-rays and a contrast medium and a fine tube that is inserted into the diseased vessels of the head via the groin.
Patients of full age who have undergone burr hole trepanation as a first operation, i.e. a blood drain through a hole in the cranial cavity, can participate in the study. Participating patients are randomly assigned to a control group with treatment according to clinical routine or a treatment group with an additional occlusion of the blood vessels in the skull. In addition, patients can consent to a genetic test to determine the relationship between a coagulation factor and the risk of recurrence of the hematoma. In order to record the test results, check-up examinations are carried out after one and three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients who have undergone surgery by means of one or more burr hole trepanations during the first manifestation of a cSDH (unihemispherical or bihemispherical) detected by computed tomography or magnetic resonance tomography
- •Age ≥18 years
- •Sufficient compliance and ability to consent
- •Patient's informed consent for surgical as well as endovascular interventional procedure and participation in the study
排除标准
- •Conservatively treated cSDH
- •Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma
- •Surgical technique: craniotomy, craniectomy, bilateral burr hole trepanation
- •Angiography cannot be performed within 72 hours after surgery
- •Age <18 years
- •Supervisory relationship
- •Lack of informed consent
- •Lack of compliance
- •Homozygous factor XIII deficiency with residual activity <10%
结局指标
主要结局
cSDH recurrence rates after surgery
时间窗: Within three months of follow-up
A recurrence occurs when at least one of the following criteria is met: * recurrent cSDH with at least the same volume (\>- 10%) compared to the findings at baseline and / or * recurrent cSDH which requires surgery
次要结局
- Number of complications associated with interventional therapy(Within three months of follow-up)
- Number of recurrence-associated complications(Within three months of follow-up)
- Impairment due to neurological deficits assessed by the modified Rankin Scale(Evaluated at three months after baseline)
研究者
Johannes Lemcke
Deputy Head Department of Neurosurgery
Unfallkrankenhaus Berlin