Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Functional outcome measured by the extended Glasgow Outcome Scale (GOS-E)
研究概览
简要总结
Intractable high intracranial pressures (ICP) are associated with poor functional outcomes and mortality, so the SCALPEL trials aims to evaluate the effect of decompressive craniectomy against decompressive laparotomy to lower those pressures in diffuse TBI. The primary outcome measure for that evaluation is functional outcome after 12 months on the extended Glasgow Outcome Scale (GOS-E).
详细描述
Rationale for trial:
Traumatic brain injuries (TBI) are held responsible for about half of the trauma related death rate and a main driver of trauma related morbidity. While outcomes from trauma have improved in the last decades, the mortality and morbidity caused by TBI stayed about the same.
The surgical interventions for raised ICP in TBI have been studied extensively with varying outcome. Craniectomy did reduce mortality in several trials. There were additional survivors with favorable neurological outcome, as well as additional survivors with poor functional outcome. That effect might partly be explained by the inherent morbidity of the craniectomy or the consecutive cranioplasty. Various studies have shown surgical complications post cranioplasty in around one third of the cases including reoperation for hematoma, hydrocephalus, seizures, and graft infections and there is evidence for negative effects due to the rapid decompression of the pressure as growing hematoma size.
Decompressive laparotomy (DL) on the other side is thought to lower not only the dynamic pulsatile effect on the brain, it also causes increased venous outflow from the brain which reduces the intracranially present amount of venous blood and therefore ICP.
It is hypothesized that a decompressive laparotomy may have the benefit of lowering the ICP, without the inherent risks and complications caused by a large craniectomy and its influence on long-term outcome.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Traumatic Brain Injury with abnormal CT scan
- •Invasive ICP monitoring in place
- •ICP >25 mmHg for 1-12h after conventional therapies step I and step II (see Trial flow chart)
排除标准
- •Bilateral fixed and dilated pupil
- •Limitation of therapies by the team due to poor prognosis
- •Withdrawal of consent
- •Severe pre-existing physical or mental disability or co-morbidity which would lead to a poor outcome even if the patient made a full recovery from the head injury
- •Intracranial injury mandating craniotomy/craniectomy in itself
- •Intraabdominal injury mandating laparotomy in itself
结局指标
主要结局
Functional outcome measured by the extended Glasgow Outcome Scale (GOS-E)
时间窗: 12 months post-injury
8 Good recovery Upper no current problems related to the brain injury that affect daily life; 7 Good recovery Lower minor problems that affect daily life; resumes \>50% of the pre-injury level of social and leisure activities; 6 Moderate disability Upper reduced work capacity; resumes \<50% of the pre-injury level of social and leisure activities; 5 Moderate disability Lower unable to work or only in sheltered workshop; 4 Sever disability Upper can be left alone \> 8h during the day, but unable to travel and/or go shopping without assistance; 3 Sever disability Lower requires frequent help of someone to be around at home most of the time every day; 2 Persistent vegetative state unresponsive and speechless; 1 Death \[higher scores mean better outcomes\]
次要结局
- Mortality(30 days post-injury)
- EQ-5D life quality(6 and 12 months post-injury)
- Crossover-rate(30 days post-injury)
- Intraabdominal pressure(while in ICU for up to 14 days or until ICU discharge, whatever occurs first)
- GCS(14 days post-injury)
- Frequency and severity of organ failure(30 days post-injury)
- Length of stay at the intensive care unit(up to 12 months)
- Length of stay at the intensive care unit (ICU), neurosurgical unit, and rehabilitation unit(up to 12 months)
- Serious adverse events and surgical complications measured by the Clavien-Dindo Scale(30 days post-injury)
- Mean airway pressure(for up to 14 days or until ICU discharge, whatever occurs first)
- Course of intracranial pressure(while in ICU for up to 14 days or until ICU discharge, whatever occurs first)
- Hernia rate in the laparotomy group(12 months post-injury)
- Length of stay at the neurosurgical unit(up to 12 months)