NCT04641767

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
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Hospital Universitario Virgen Macarena · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Traumatic Brain Injury
• Moderate Traumatic Brain Injury

Timeline

• Start date: 2020-10-28
• Primary completion: 2022-02-14
• Completion: 2022-02-21
• First posted: 2020-11-24
• Last updated: 2022-02-22

Locations

9 sites across 1 country: Spain