BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)

Hospital Universitario Virgen Macarena200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Mild Traumatic Brain Injury Moderate Traumatic Brain Injury

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (9)

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Sant Joan Deu Barcelona

Esplugues de Llobregat, Barcelona, Spain

Complejo Hospitalario La Mancha Centro

Alcázar de San Juan, Ciudad Real, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Mallorca, Spain

Hospital Virgen del Rocio

Seville, Seville, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Hospital Infantil Niño Jesus

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Virgen Macarena

Seville, Spain

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: through study completion, an average of 2 years