The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma - A Multicenter Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 588
- 试验地点
- 3
- 主要终点
- Recurrence rate
研究概览
简要总结
The study will be a multicenter randomised controlled trial of the use of irrigation fluid of body temperature versus irrigation fluid of room temperature during burr hole evacuation of chronic subdural hematoma.
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
- Triple (Participant, Investigator, 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 with chronic subdural hematoma requiring burr hole evacuation.
- •Patients older than 18 years of age.
排除标准
- •Chronic subdural hematoma requiring surgical treatment other than burr hole evacuation.
- •Chronic subdural hematoma in a patient with an intracranial arachnoidal cyst.
- •Chronic subdural hematoma in a patient with a Cerebro Spinal Fluid-shunt.
- •Patients who have undergone intracranial surgery before.
研究组 & 干预措施
Irrigation fluid of body temperature
During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of body temperature (approximately 37 degrees Celsius)
干预措施: Irrigation fluid of body temperature (Procedure)
Irrigation fluid of room temperature
During burr hole evacuation of the chronic subdural hematoma the irrigation fluid used will be of room temperature (approximately 22 degrees Celsius)
干预措施: Irrigation fluid of room temperature (Procedure)
结局指标
主要结局
Recurrence rate
时间窗: 6 months
Recurrences requiring repeat surgery during a 6-month follow up period
次要结局
- Mortality(6 months)
- Complications related to the surgery(6 months)
- Health related quality of life(6 months)
研究者
Andreas Bartley
MD, neurosurgical resident
Sahlgrenska University Hospital, Sweden