Impact of an Early Out-of-bed Paradigm in Postoperative Outcomes of Chronic Subdural Hematomas: GET-UP Randomized Prospective Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Medical Complications
研究概览
简要总结
Compare rates of medical complications, recurrence and outcome in 2 randomized groups of patients with surgical chronic subdural hematomas. The intervention group will be assigned to early mobilization (within 12 hours of the surgical procedure). The control group will be assigned to bed rest for 48 hours.
详细描述
At Centro Hospitalar do Porto it is routinely used burr hole craniostomy with subdural drains and 48 hours of bed rest for the surgical treatment of chronic subdural hematomas. After 48 hours the subdural drains are removed and the patient is allowed to mobilize for the first time.
The aim of the present study is to conduct a prospective, randomized, controlled trial with an early mobilization protocol vs 48 hours bed rest to determine the best strategy to reduce postoperative complications and improve functional outcomes.
There will be 2 groups:
- Control group: bed rest 48 hours post-surgery with removal of subdural drains after this period.
- Intervention group: Early mobilization protocol: as early mobilization as possible, within a maximum of 12 hours following surgery, with progressive autonomization in the ward as tolerated by the patient. Mobilization time will be recorded. At the time of assuming an upright position the drains will be closed and will only be open again when the patient is in supine position (8 hours per day of supine position). Subdural drains will be removed after 48 hours, similar to the practice in the control group.
Primary End-Point:
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
- •Surgically drained chronic subdural hematomas (Burr hole craniostomy)
- •> or equal to 18 years old
排除标准
- •Previous neurosurgery
- •Surgery for another pathology performed at the same time
- •> 6h sedation post-surgery
- •Any previous condition that makes early mobilization impossible
结局指标
主要结局
Medical Complications
时间窗: From date of randomization until 3 months post-randomization
Infections, venous thromboembolism, seizures
次要结局
- Survival(At 3 months follow-up)
- Length of hospital stay(From date of randomization until clinical discharge up to 36 months)
- Post-operative GOS-E scale(At 3 months follow-up)
- Recurrence(At 3 months follow-up)
- Post-operative Modified Rankin scale(At 3 months follow-up)
研究者
Sérgio Sousa
Principal Investigator
Centro Hospitalar do Porto