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BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS) — BIOTRABIS  

Mild Traumatic Brain Injury Clinical Trial

Official title:
"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."

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04641767
Study type Observational
Source Hospital Universitario Virgen Macarena
Contact
Status Completed
Phase
Start date October 28, 2020
Completion date February 21, 2022
View Details
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