RecruitingNCT07311486

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

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

Sponsor

Hospital Universitario 12 de Octubre

Enrollment

1,000 participants

Start Date

Jul 15, 2025

Study Type

OBSERVATIONAL

Conditions

Mild traumatic brain injury (MTBI)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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.

Exclusion Criteria8

· 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