Early eNdovascular Embolization for Chronic subduraL hematOma After SUrgery and Prevention of REcurrence (ENCLOSURE)
试验速览
- 阶段
- 不适用
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Recurrence of chronic subdural hematoma
研究概览
简要总结
Chronic subdural hematomas (CSH) are one of the most frequent pathologies in emergency neurosurgical practice. Standard therapy for symptomatic CSH is surgical drainage. However, the recurrence rate after surgery is high (10 to 20% in the most of series, although it has been reported from 2 to 37%). Middle meningeal artery embolization (MMAE) is a promising minimally invasive procedure that has recently been proposed as an alternative or adjunctive treatment to surgery. The investigators hypothesize that early post operative endovascular treatment can reduce the recurrence rate in high-risk patients, improving neurological outcomes by reducing the need for reinterventions, hospitalizations, and post-operative complications. The aim of the investigators is to analyze the efficacy of and safety of early post-surgical embolization of MMA in reducing the risk of CSH recurrence.
详细描述
The study was designed as an open-label, multicenter randomized trial involving patients with symptomatic CSH and surgical evacuation criteria. Patients will be randomized in a 1: 1 ratio to receive surgical drainage (the standard of care) or surgical drainage plus early endovascular embolization of MMA (< 72 hours after surgery). Endovascular procedures will be performed with non-adhesive embolizing fluids. The primary outcome will be the recurrence of CSH at 6 months and secondary outcomes will be the risk reduction of recurrence in patients with risk factors, functional status measured by the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 6 months and complications related to endovascular procedure.
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)
盲法说明
Primary outcome will be assesed by a blinded external core lab
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic subdural hematoma equal or greater than 10 mm, midline shift equal or greater than 5 mm or neurological symptoms attributable to mass effect.
- •Recent diagnosis or recurrence
- •Surgical treatment performed < 72 hours
- •Informed consent signed by the patient or they responsible family member
排除标准
- •Advanced disease with life expectancy < 6 months
- •Condition that contraindicated endovascular procedure: Pregnancy, renal failure defined as creatinine clearence < 30 ml/min, allergy to iodinated contrast.
- •Unavailability for follow up st 6 months
- •Patient expressly refuses treatment
结局指标
主要结局
Recurrence of chronic subdural hematoma
时间窗: 6 months
Defined ad reappearance of symptomatic blood collection or whose thickness is \> 1 cm or which determines a deviation from the midline\> 5 mm
次要结局
- Functional status(6 months)
- Safety of endovascular treatment(6 months)
- Hematoma reabsorption speed(6 months)
- Cumulative days of hospital stay(6 months)