Added Value, Performance and Acceptance of the "GFAP-UCH-L1" Pair in the Evaluation of Subjects with Mild Traumatic Brain Injury (MTBI) At Intermediate Risk of Complications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 15
- 主要终点
- performance of UCH-L1 and GFAP combined to rule out intracranial complication after MTBI
研究概览
简要总结
The goal of this observational study is to evaluate the performance of UCH-L1 and GFAP combined in patients with a mild traumatic brain injury. The main question :
• Does the combination of UCH-L1 and GFAP can exclude brain injuries detected with CT scan in the first twelve hours after a mild traumatic brain injury?
Participants will do the exams planed in routine care and :
- during the expected blood sampling an additional blood sample will be done,
- seven days after the discharge a call will be done by the investigator.
详细描述
Main study
The main study includes subjects presenting to the emergency department within 12 hours of mild traumatic brain injury with an intermediate risk of clinical worsening or intracranial lesions.
The participants have at least one of the following characteristics, as defined in the French recommendations
- > 65 years treated with anti-platelet agents
- Glasgow Score < 15 at two hours after the trauma if associated intoxication (alcohol, narcotic, psychotropic)
- Trauma with high kinetics (for information only: a risk mechanism (pedestrian knocked down by a motorized vehicle, ejection from a vehicle, fall from more than 3 steps (more than one meter), etc.),
- Amnesia of facts > 30 min before the trauma
The study includes clinical sites in France and Monaco. Participants have a blood sample and a brain scan as part of the care. The participation of subjects in the study will not influence their treatment.
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
- •Traumatic brain injury defined by
- •Impact on the skull or the face AND OR
- •Acceleration / deceleration
- •Glasgow Coma Scal 13, 14 or 15
- •One of the following 4 criteria:
- •> 65 years treated with anti-platelet agent,
- •GCS < 15 two hours after the trauma if associated intoxication (alcohol, narcotic, psychotropic),
- •Trauma with high kinetics (for information only: a risk mechanism (pedestrian knocked down by a motorized vehicle, ejection from a vehicle, fall from more than 3 steps (more than one meter), etc.),
- •Amnesia of facts > 30 min before the trauma.
- •Having a blood sample taken as part of care with a delay between the clinical event and the biological sample < 12 hours
- •Having a CT-scan prescription as part of the MTBI evaluation
- •Patient who signed an informed consent form
排除标准
- •Person not affiliated or not benefiting from a health insurance scheme.
- •Person under judicial protection.
- •Person with restrictions of freedom or subject to Articles L.3212-1 and L.3213-1, and not included in Article L.1122-8 of the French CSP
- •Blood collection time > 12 hours
- •Subjects for which a scan would be carried out systematically, including:
- •GCS <13 (moderate or severe trauma),
- •congenital hemostasis disorders or patient on anti-coagulant treatment,
- •clinical signs evoking a fracture of the vault or the base of the skull,
- •more than one episode of vomiting,
- •post-traumatic convulsion,
- •focal neurological deficit.
- •Obstacle to follow-up at D7
- •Malignant melanomas
结局指标
主要结局
performance of UCH-L1 and GFAP combined to rule out intracranial complication after MTBI
时间窗: during the first 12 hours
Percentage of intracranial lesion excluded by UCH-L1 and GFAP combined, versus the CT scan, within the first 12 hours following a MTBI
次要结局
- Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI(during the first 12 hours with a focus every 3 hours)
- Comparation of UCH-L1 and GFAP combined or alone, to S100b protein (PS100b)(during the first 12 hours with a focus every 3 hours)
- Predicted impact of using UCH-L1 and GFAP combined(day 7)
- Performance of UCHL-1 and GFAP alone or combined to predict complications(during the first 7 days)