A Prospective Outcome Study in Patients With Moderate to Severe Traumatic Brain Injury in Bergamo Area (Italy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Glasgow Outcome Scale - Extended (GOSE)
研究概览
简要总结
Traumatic brain injury (TBI) is the leading cause of death, disability and cognitive impairment in young people worldwide. The majority of the traumatic deaths in developed countries results directly from lesions in the central nervous system. Furthermore, due to the persistence of disabling effects of TBI for many years, personal and public costs of supporting survivors have to be taken in consideration.
Many patients rescued by ICU treatment may have been severely disabled or vegetative because of trauma. These data suggest that, despite improvement in medical and surgical treatments, other factors related to trauma itself and to patient's condition could have an impact on the final outcome.
Aim of the TBI-PRO project is to collect high quality clinical and epidemiological data and to describe the outcome of moderate-to-severe TBI in a local contest (Bergamo area, Italy).
详细描述
All patients admitted to the ICU with a diagnosis of moderate-to-severe TBI, with or without polytrauma, are recruited. Bergamo hospital is the main Trauma Centre (Level I) and the only referring neurosurgical center within a population of 1.2 million inhabitants of Bergamo area. This hospital is also a Regional Pediatric Trauma Centre.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admission to ICU
- •diagnosis of moderate-to-severe TBI
排除标准
- •Patients who died in the first couple of hours after hospital admission are not included.
结局指标
主要结局
Glasgow Outcome Scale - Extended (GOSE)
时间窗: 12 Months Post-Injury
The global functional outcome at 12 months is assessed using the Glasgow Outcome Scale-Extended (GOS-E), obtained through structured interview. The GOS-E is a well-validated, widely employed measure of disability based on information on independence, employability, and social/community participation. The baseline function prior to injury is assessed to ensure that the deficit can be attributed to the event. GOS-E is dichotomized into favorable (a score of 5 to 8, Moderate Disability is defined by a score of 5-6) and unfavorable (a score of 1 to 4, Dead is defined by a score of 1).
次要结局
- Neuropsychological evaluation(12 Months Post-Injury)
- 6-Month Outcome(6 Months Post-Injury)