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Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study
Sponsor: Hospital Universitario 12 de Octubre
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
Conditions
Interventions
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