BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04641767

Acronym

BIOTRABIS

Enrollment

200

Registered

2020-11-24

Start date

2020-10-28

Completion date

2022-02-21

Last updated

2022-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Traumatic Brain Injury, Moderate Traumatic Brain Injury

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Brain damage diagnostic accuracy	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	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.

Countries

Spain

Outcome results