BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury

Participation Criteria
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Eligibility Criteria
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BIOTRABIS>18 (adult patients) Inclusion Criteria: 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 Exclusion Criteria: Recent history (<1 month) of TBI Refusal to participate in the study Evidence of alcohol or other substance intoxication Epilepsy 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 Epilepsy Schizophrenia
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BIOTRABIS>18 - Pathologic patients<br>Group that includes adult patients under study. Those with mild TBI will be recruited. In order to determine the severity of the mild TBI, the doctor uses a scale called the Glasgow GCS scale and mild TBI is understood as those with GCS: 14-15. | |
| BIOTRABIS>18 - Control patients<br>Group that includes adult control patients. Those with very mild TBI will be recruited (GCS: 15) without symptoms | |
| BIOTRABIS<18 - Pathologic patients<br>Group of paediatric patients under study. This will recruit those who come to the emergency department with mild TBI (GCS 14-15) or moderate (GCS 9-13). | |
| BIOTRABIS<18 - Control patients<br>Group that includes paediatric control patients. Those with very mild TBI will be recruited (GCS: 15) without symptoms | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain damage diagnostic accuracy | 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. | through study completion, an average of 2 years | 
| Brain damage long term diagnostic accuracy | 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. | through study completion, an average of 2 years |