Nuevos Biomarcadores y Tecnologia Para Una Mejores Reglas de predicción en el Traumatismo craneoncefálico Leve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Biomarkers diagnostic performance
研究概览
简要总结
Mild traumatic brain injury(mTBI) is a common cause of consultation to the emergency rooms worldwide and is the most common form of traumatic brain injury. Though classified as mild, as many as 40% of patients suffering mTBI do not make complete recoveries or present persistent symptoms. The present study is intended to determine long term outcome of patients suffering mTBI and to establish new prognostic models with the use of serum and saliva based biomarkers. For this purpose this study will not exclude patients regarding their comorbidities.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild TBI (GCS 13-15 on admission)
- •Blood sample obtained ≤24h after injury
排除标准
- •GCS 3-12 on admission
- •Time of injury unknown
- •Time to injury exceeding 24 hours
- •Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)
- •Penetrating head trauma
- •Patient with mechanical ventilation from the trauma scene or prehospital management.
- •Venipuncture not feasible
- •Subject under judiciary control
结局指标
主要结局
Biomarkers diagnostic performance
时间窗: 24 hours after mild TBI
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1, S100B, Osteopontin, SAA1, YKL-40, Copeptin, NSE, C reactive protein, procalcitonin to detect the presence or absence of intracranial lesions on CT scan
次要结局
- Determination of the potential of the biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI(1 week, 3 months, 6 months and 1 year)
- Determination of the potential of the biomarkers in predicting quality of sleep assessed by the Epworth and Pittsburgh Scales(3 months, 6 months and 1 year)
- Determination of the potential of the biomarkers in predicting neurological symptoms after TBI(1 week, 3 months, 6 months and 1 year)
- Determination of the potential of the biomarkers in predicting quality of life assessed by Qolibri-OS after TBI(1 week, 3 months, 6 months and 1 year)
- Determination of the potential of the biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI(3 months, 6 months and 1 year)