Blood Biomarkers to Improve Management of Mild Traumatic BRAIN Injury in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,297
- 试验地点
- 7
- 主要终点
- Biomarkers diagnostic performance
研究概览
简要总结
Mild traumatic brain injury (mTBI) is one of the most frequent emergencies in the elderly population. Despite most mTBI are managed with cranial computed tomography (CT), only 10% of CTs show lesions, determining CT overuse. The use of serum glial fibrillary acidic protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) have shown potential for ruling out the need for cranial CT. However evidence on biomarker use in mild TBI were not based on studies that included aged participants and patients with comorbidities for which biomarker levels could vary. This is why there is a need for a prospective study that assesses the predictive performance of these two biomarkers in the elderly population, both in elderly patients suffering mild TBI and in a reference population, including patients and participants with and without 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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC:
- •Patients ≥65 years of age
- •Mild TBI (GCS 13-15 on admission) with indication of brain CT scan in the 12 hours after injury ;
- •Blood sample obtained ≤12 h after injury and CT scan preferably ≤6h from blood sample.
- •BRAINI2-ELDERLY REFERENCE:
- •Non TBI patients ≥65 years of age
排除标准
- •BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC:
- •Age below 65 years.
- •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 from the trauma scene or prehospital management.
- •Venipuncture not feasible
- •No realization of brain CT-scan
- •Subject under judiciary control
- •Subject in inclusion period of a drug interventional study
- •BRAINI2-ELDERLY REFERENCE:
- •Subject in inclusion period of another drug interventional study
- •Patients harboring a brain tumor
- •Patients that have had a stroke or neurosurgical operation 1 month prior to the inclusion in the study.
结局指标
主要结局
Biomarkers diagnostic performance
时间窗: 12 hours after mild TBI
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1 used separately and in combination to detect the presence or absence of intracranial lesions on CT scan
次要结局
- Determination of the potential of the two biomarkers in predicting neurological symptoms after TBI(1 week and 3 months)
- GFAP reference values(1 Day, day of extraction of the sample)
- UCHL-1 reference values(1 Day, day of extraction of the sample)
- Determination of the potential of the two biomarkers in predicting quality of life assessed by Qolibri-OS after TBI(1 week and 3 months)
- Determination of the potential of the two biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI(1 week and 3 months)
- Determination of the potential of the two biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI(3 months)
- Determination of the potential of the two biomarkers in depression symptoms assessed by PHQ-9 after TBI(3 months)
研究者
Alfonso Lagares Gómez-Abascal
Department of Neurosurgery, Head
Hospital Universitario 12 de Octubre