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RECRUITING
NCT07311486

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

Sponsor: Hospital Universitario 12 de Octubre

View on ClinicalTrials.gov

Summary

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.

Official title: BLOOD BIOMARKERS TO IMPROVE MANAGEMENT OF MILD TRAUMATIC BRAIN INJURY IMPLIMENTACIÓN STUDY

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2025-07-15

Completion Date

2026-05-01

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

GFAP and UCH-L1

Serum test to measure the concentration of GFAP and UCH-L1

Locations (1)

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain