Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study

This study aims to evaluate the real-world applicability and clinical added value of a new management pathway for patients presenting to the emergency department (ER) with mild traumatic brain injury (mTBI). The pathway includes the use of the VIDAS® TBI in vitro diagnostic assay, which measures the blood biomarkers GFAP and UCH-L1 within 12 hours of injury to determine whether a CT scan is necessary. The study seeks to answer two primary questions: 1. Safety and effectiveness: Whether the VIDAS® TBI test can safely and accurately rule out the need for head CT in mTBI patients in routine emergency care. 2. Clinical and operational impact: Whether incorporating this test reduces the number of CT scans performed and shortens ER length of stay for patients with mild TBI. To assess these outcomes, researchers will compare patient management using the new biomarker-based pathway to a historical cohort of mTBI patients who were managed without the biomarker test.

NCT Number	NCT07311486
Lead Sponsor	Hospital Universitario 12 de Octubre
Conditions	Mild Traumatic Brain Injury (mTBI)
Enrollment	1,000 participants
Start Date	2025-07-15
Primary Completion	2026-05-01 (estimated)
Study Completion	2026-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-31