The Association Between Initial Concentrations of Biomarkers and Outcome 1 and 10-15 Years After Severe Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- In severe traumatic brain injury patient; Correlation of Neurochemical biomarkers analyzed in CSF and serum, assessed in the initial ICU period, correlated to Glasgow Outcome Scale (GOS) at 1 year post-trauma
研究概览
简要总结
After written consent from next-of-kin patients with severe traumatic brain injury was included from the neurointensive care unit (NICU) at Sahlgrenska university hospital, Gothenburg. Blood and CSF samples were collected during the initial 3 weeks after trauma. 1 year after trauma patients were assessed according to Glasgow outcome scale (GOS), NIHSS and Barthels. 10-15 years after trauma a repeated evaluation according to GOS was performed by telephone. Different biomarkers such as Neurofilament light, Glial fibrillary acidic protein and Tau among others, was analyzed from serum and CSF samples. Further patients were explored Apolipoprotein-E genetype (APOE). The investigators hypothesize that higher biomarkers concentrations and positive test for this gene relate to worse outcome 1-year and 10-15 years after trauma. Further that these biomarkers and genetic marker further have prognostic value on outcome 1-year and 10-15 years after trauma. Finally, the investigators want to explore the concentrations dynamics of these biomarkers in serum and CSF in the acute phase after trauma.
详细描述
Patients with a severe traumatic brain injury (sTBI) were included after written consent from next-to kin. The injury was considered as severe if having a Glasgow coma scale of 8 or less. Within 48h of trauma patients were included from the neurointensive care unit at Sahlgrenska university hospital, Gothenburg during 2000-2004. Patients were intubated and had a ventricular catheter. All patients were treated in accordance with the Lund Concept. Samples from ventricular cerebrospinal fluid (CSF) and blood was collected, during the first 3 weeks, then prepared for storage and later analyzed. Samples were stored in -70 degrees Celsius until analyzed. 1 year after trauma patients were assessed according to Glasgow outcome scale (GOS), NIHSS and Barthels Index. 10-15 years after trauma an evaluation of GOS by phone was repeated. Biomarkers such as Neurofilament light, Glial fibrillary acidic protein, Tau among others is analyzed in serum and CSF. Further, patients APOE genotype was explored. The investigators hypothesizes that higher concentrations of these biomarkers both in serum and CSF relate to worse 1-year and 10-15 year outcome after a severe traumatic brain injury. Further, patients that have the gene APOE4 is predisposed to worse 1 year and 10-15 year outcome after a sTBI. The investigators further want to explore the dynamics of these biomarkers in serum and CSF in the acute phase after trauma and if these biomarkers gave any prognostic value to on outcome (mortality and functional) 1-year and 10-15 years after trauma.
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
- •Reaction level scale >3, corresponding to a Glasgow coma scale <9
- •A therapeutic indication for intracranial pressure monitoring
- •Need for ventilator treatment
排除标准
- •Not residing in Sweden
结局指标
主要结局
In severe traumatic brain injury patient; Correlation of Neurochemical biomarkers analyzed in CSF and serum, assessed in the initial ICU period, correlated to Glasgow Outcome Scale (GOS) at 1 year post-trauma
时间窗: 1 year after trauma
GOS 1-3 - Poor outcome, GOS 4-5 Good outcome
In severe traumatic brain injury patient; correlation of the genetic alleles of APOE correlated to Glasgow Outcome Scale (GOS) at 1-year post-trauma)
时间窗: 1 year after trauma
GOS 1-3 - Poor outcome, GOS 4-5 Good outcome
In severe traumatic brain injury patient; Correlation of Neurochemical biomarkers analyzed in CSF and serum, assessed in the initial ICU period, correlated to Glasgow Outcome Scale (GOS) at 10-15 years post-trauma
时间窗: 10-15 years after trauma
GOS 1-3 - Poor outcome, GOS 4-5 Good outcome
In severe traumatic brain injury patient; correlation of the genetic alleles of APOE correlated to Glasgow Outcome Scale (GOS) at 10-15 years post-trauma)
时间窗: 10-15 years after trauma
GOS 1-3 - Poor outcome, GOS 4-5 Good outcome
次要结局
未报告次要终点
研究者
Bengt Nellgard
Associate professor
Sahlgrenska University Hospital, Sweden
