A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,501
- 试验地点
- 16
- 主要终点
- Performance of the VIDAS-BTI assay in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and their corresponding lower limit of 95% confidence interval by comparison with brain CT scan findings.
研究概览
简要总结
Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 >18 years old (France)
- •Mild TBI (GCS 13-15 on admission) within 12 hours after injury
- •Indication of brain CT scan:
- •neurological focal deficit
- •anterograde amnesia
- •Glasgow coma scale score <15 after 2 hours post-TBI
- •suspicion of vault depression fracture
- •fracture of the basal skull
- •persisting nausea, vomiting or headache
- •post-TBI seizures
- •Pre-injury treatment with antithrombotic drugs
- •Loss of consciousness or amnesia with age >65 years, fall >1m or hit pedestrian
- •Other condition requiring CT scan according to the in-charge physician.
排除标准
- •GCS 3-12 on admission
- •Time of injury unknown
- •Time to injury exceeding 12 hours
- •Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous intracranial hematoma)
- •Penetrating head trauma
- •Patient with mechanical ventilation
- •Pre-injury neurological disorder affecting the assessment of neurological outcome: dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumor, and history of neurosurgery, stroke or transient ischemic attack (TIA) within the last 30 days
- •Venipuncture not feasible
- •No realization of brain CT-scan
- •Subject under judiciary control
- •Pregnant or breastfeeding woman
- •Subject in exclusion period of another study
结局指标
主要结局
Performance of the VIDAS-BTI assay in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and their corresponding lower limit of 95% confidence interval by comparison with brain CT scan findings.
时间窗: 12 hours post Traumatic Brain Injury (TBI)
2 x 5mL blood sample
次要结局
- Determination the potential of the two biomarkers in predicting neurological outcome(3 month after TBI)
- Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home(7 days after traumatic brain injury (TBI))
- Determination of the potential of the two biomarkers in predicting neurological outcome(3 month after TBI)