A Randomized Controlled Trial of Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 309
- 试验地点
- 17
- 主要终点
- Rate of re-operations of chronic subdural hematoma
研究概览
简要总结
A prospective, multicenter, randomized controlled trial is designed to compare the recurrence rates and clinical outcomes in patients with chronic subdural hematoma using exhaustive drainage or fixed-time drainage after one-burr hole craniostomy.
详细描述
Chronic subdural hematomas (CSDHs) are one of the most common neurosurgical conditions. The goal of surgery is to alleviate symptoms and minimize the risk of symptomatic recurrences. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural closed-system drainage. The drainage is removed after 48 hours, which can be described as fixed-time drainage strategy. According to literature, the recurrence rate is 5-33% with this strategy. In the investigators' retrospective study, postoperative hematoma volume (p=0.001, B=0.028, Exp(B)=1.028, 95% CI 1.011-1.046) was found to significantly increase the risk of recurrence. Based on these results, an exhaustive drainage strategy may minimize postoperative hematoma volume and achieve a low recurrence rate and good outcomes. This is a prospective, multicenter, randomized controlled trial designed to include 304 participants over the age of 18 years presenting with a symptomatic CSDH verified on cranial computed tomography or magnetic resonance imaging. After informed consent is obtained, participants are randomly allocated to an exhaustive drainage or fixed-time drainage group. The primary endpoint is recurrence indicating a reoperation within 6 months. Secondary outcomes include modified Rankin Scale, Markwalder Grading Scale, European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L), rate of complications, rate of adverse events and effect on comorbidity.
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
The design is open labeled with only the investigators for postoperative follow-up evaluation, the outcome assessors, and data analysts being blinded in all 19 centers. Before outcome assessment begins at every follow-up evaluation, the patients will be reminded not to reveal any information about their group allocation. If details of group allocation can be detected by the investigator during follow-ups, another blinded researcher will replace to evaluate outcome.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of chronic subdural hematoma
- •Chronic subdural hematoma verified on cranial computed tomography or magnetic resonance imaging
- •Written informed consent from patients or their next of kin according to the patient's cognitive status
排除标准
- •No clinical symptoms correlating with chronic subdural hematoma
- •Lack of mass effect, less than 0.5 cm of midline structure shift, and no need surgery judged clinically by neurosurgeons
- •Previous surgery for chronic subdural hematoma during the past 6 months
- •Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before
- •Existing poor medication condition or severe comorbidity so that surgery cannot be tolerated or follow-up cannot be completed
- •Severe coagulopathy or high risk of life-threatening bleeding
- •Postoperative cooperation is suspected to be insufficient for follow-up for 6 months
- •Reproductive-age women without verified negative pregnancy testing
- •Participating in other research
结局指标
主要结局
Rate of re-operations of chronic subdural hematoma
时间窗: From operation up to 6 months postoperatively
Rate of re-operations between fixed-time drainage group and exhaustive drainage group
次要结局
- Change of Modified Rankin Scale (MRS) between groups from baseline to 6 months after operation(At baseline, and at 1, 3, and 6 months after operation)
- Change of Markwalder Grading Scale (MGS) between groups from baseline to 6 months after operation(At baseline, and at 1, 3, and 6 months after operation)
- Change of health related quality of life between groups from baseline to 6 months after operation(At baseline, and at 1, 3, and 6 months after operation)
- Rate of complications and adverse events between groups within 6 months(From operation up to 6 months postoperatively)
- Rate of mortality between groups within 6 months(From operation up to 6 months postoperatively)
研究者
Weiming Liu
Professor
Beijing Tiantan Hospital