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

NCT07311486 | Recruiting

• 1 other identifier: TP25/0144
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Mild Traumatic Brain Injury (mTBI)

Keywords

Biomarker; GFAP; UCH-L1; Implementation

Outcome Measures

Primary Outcomes (2)

• Diagnostic performance of the biomarker test

  Sensitivity, specificity and NPV of the combined biomarker test to determine the presence of lesions on CT

  12 hours after mild TBI

• Proportion (%) of CT scan prescribed in the ER over the period of the study for patients with mTBI

  Proportion of patients in whom a CT scan has been performed for screening of intracranial lesiones

  12 hours after mild TBI

Secondary Outcomes (2)

• Time spent in the ED

  12 hours after mild TBI

• Compliance with proposed algorithm

  12 hours after mild TBI

Study Arms (2)

Pre-implemetation Mild TBI cohort

Mild TBI patients managed before the implementation of the combined GFAP UCH-L1 test

Post-implementation Mild TBI cohort

Prospective Mild TBI patients managed following a clinical pathway including the use of the combined GFAP UCH-L1 diagnostic test in a real world enviroment

Diagnostic Test: GFAP and UCH-L1

Interventions

GFAP and UCH-L1 DIAGNOSTIC_TEST

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

Post-implementation Mild TBI cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mild traumatic brain injured patients admitted in the ER less than 12 hours after injury

You may qualify if:

• All adult patients suffering mild TBI:( Defined by at least criterion a) and d) and one or more of the other criteria)
• The presence of a plausible traumatic mechanism observed/or related by the patient´s recount of the injury event.
• Presence of one or more clinical signs attributable to brain injury: Loss of consciousness immediately following injury, alteration of mental status immediately following the injury, posttraumatic amnesia or any neurological abnormality.
• At least two acute symptoms related to the injury: feeling confused or disoriented, headache, nausea, vomiting, dizziness, vision problems, memory problems, emotional lability or irritability.
• a GCS between 15 and 13, at least 30 minutes after injury.
• Blood sample obtained ≤12 h after injury and ideally before any imaging prescription.

You may not qualify if:

• · GCS 3-12 on admission
• Age Below 18 years
• Time of injury unknown
• Time to injury exceeding 12 hours
• Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)
• Penetrating head trauma
• Patient with mechanical ventilation from the trauma scene or prehospital management
• Venipuncture not feasible

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Alfonso Lagares, MD, PhD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfonso Lagares, MD, PhD

CONTACT

+34913908000; alfonlag@ucm.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery, Head of Department Neurosurgery

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 31, 2025
• Study Start: July 15, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: De-identified individual participant data will be available from 6 months to 5 years after publication of the study results, upon reasonable request. After this period, data availability cannot be guaranteed.
• Access Criteria: Access to de-identified individual participant data will be granted only upon reasonable request to researchers who submit a methodologically sound proposal and whose intended use is consistent with the study objectives and ethical standards. Requestors must sign a data-sharing agreement outlining conditions for data use, confidentiality, and prohibition of re-identification. Access will be limited to qualified researchers affiliated with recognized academic or clinical institutions.

Locations

ES (1)