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

Recruiting now

Conditions studied: Mild Traumatic Brain Injury (mTBI)

In brief

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.

Key facts

Study ID

NCT07311486

Run by

Hospital Universitario 12 de Octubre

People needed

1000

Starts

2025-07-15

Expected to finish

2026-05-01

Last updated by the study team

2025-12-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Hospital Universitario 12 de Octubre — Madrid, Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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