NCT03780062已完成3 期
Interest of S100B Protein for Patient Victim of Minor Traumatic Brain Injury and Treated by Antiplatelet
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 4
- 主要终点
- Brain scanner Detection of a cerebral lesion requiring a surgery or medical intervention or an hospitalisation for a patient who have serum level of S100B protein with the treshold of 0.105 μg/L
研究概览
简要总结
All the patients admitted in emergency department for minor traumatized cranial, with antiplatelet therapy, can be included, after checked inclusion and non inclusions criterias. If they are agree, a blood sample for the dosage of S100b will be done.
No other modification of the medical care, all patients will have tomodensitometria, according with recommendations. The aim of the study is to validate the negative predictive value of S100b in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age > 18 Years old
- •Minor traumatic brain injury measured by a Glasgow score between 13 and 15
- •Antiplatelet agent therapy
- •Free subject without tutorship or curatorship
排除标准
- •Age < 18 years old
- •Glasgow score <13
- •Traumatic brain injury older than 6 hours
- •Patient without any social security system
- •Patient with renforced protection (tutorship, curatorship, …)
研究组 & 干预措施
S100B protein dosing
Experimental
干预措施: S100B protein dosing (Biological)
结局指标
主要结局
Brain scanner Detection of a cerebral lesion requiring a surgery or medical intervention or an hospitalisation for a patient who have serum level of S100B protein with the treshold of 0.105 μg/L
时间窗: 3 hours
次要结局
未报告次要终点
研究者
研究点 (4)
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