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

NCT07311486 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-12-31

No results posted yet for this study

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.

Conditions

  • Mild Traumatic Brain Injury (mTBI)

Interventions

DIAGNOSTIC_TEST

GFAP and UCH-L1

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

Sponsors & Collaborators

  • Hospital Universitario 12 de Octubre

    lead OTHER

Principal Investigators

  • Alfonso Lagares, MD, PhD · Hospital Universitario 12 de Octubre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2026-05-01
Completion
2026-05-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07311486 on ClinicalTrials.gov