"Fast Heart Fatty Acid Binding Protein (H-FABP) Determination to Rule Out Brain Damage in Mild Traumatic Brain Injury (TBI): the First Multicenter Study Using a Point of Care Device at Trauma and Pediatric Emergency Departments."
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Brain damage diagnostic accuracy
研究概览
简要总结
Traumatic brain injury (TBI) is defined as a structural alteration of brain function caused by external causes, where mild traumatic brain injury (mTBI) represents approximately 80% of all TBI, and although its prognosis is relatively good, it represents a significant cost to the system due to the need to perform a cranial computed tomography (CT) scan, a test of high economic value and not without risks such as irradiation, especially important and dangerous in the pediatric age.
The investigators aim to set-up a point of-care (POC) device to validate a biomarker (H-FABP) able to diagnose the presence of brain damage in children and adults with mTBI at trauma and paediatric Emergency Departments using a blood sample, in order to save resources and avoid subjecting patients to a potentially damaging imaging test. But also, to assess whether the incorporation of new biomarkers improves the prediction of brain damage that can be done with H-FABP.
For that, the investigators will recruit a 400 patients' cohort with blood samples using the available POC device for H-FABP biomarker.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Mild TBI patients the first 24 hours after trauma with GCS of 14-15 points.
- •Presence of any of the following symptoms:
- •Loss of consciousness less than 30 minutes, the first 20 minutes after trauma
- •Post-traumatic amnesia less than 24 hours, the first 30 minutes after trauma:
- •Persistent headache
- •Nausea / vomiting
- •Vertigo / dizziness
- •Confusion / disorientation
排除标准
- •Recent history (<1 month) of TBI
- •Refusal to participate in the study
- •Evidence of alcohol or other substance intoxication
- •Schizophrenia
- •BIOTRABIS<18 (paediatric patients)
- •Inclusion Criteria:
- •Patients between 0 and 17 years old.
- •Mild TBI (GCS 14-15) and moderate TBI (GCS 9-13) patients the first 24 hours after trauma.
- •Presence of any of the following symptoms:
- •Loss of consciousness less than 30 minutes, the first 20 minutes after trauma
- •Post-traumatic amnesia less than 24 hours, the first 30 minutes after trauma:
- •Persistent headache
- •Nausea / vomiting
- •Vertigo / dizziness
- •Confusion / disorientation
- •Exclusion Criteria:
- •Recent history (<1 month) of TBI
- •Refusal to participate in the study
- •Evidence of alcohol or other substance intoxication
- •Schizophrenia
结局指标
主要结局
Brain damage diagnostic accuracy
时间窗: through study completion, an average of 2 years
Brain damage diagnostic in mild TBI patients during hospital admission \[% brain damage versus % non brain damage\] will be determined by clinical and neuroimaging criteria (CT) at emergency departments arrivals and compared with diagnostic accuracy of a blood biomarker based test.
Brain damage long term diagnostic accuracy
时间窗: through study completion, an average of 2 years
Brain damage diagnostic in mild TBI patients after 3 months \[% brain damage long term versus % non brain damage long term \] will be determined by Glasgow Outcome Score (GOSe) through telephone call and compared with previous diagnostic accuracy of a blood biomarker based test.
次要结局
未报告次要终点
研究者
Joan Montaner Villalonga
Joan Montaner, MD, PhD
Hospital Universitario Virgen Macarena