Actively Recruiting
Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study
Led by Hospital Universitario 12 de Octubre · Updated on 2025-12-31
1000
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with mild traumatic brain injury (mTBI) defined by:
- A plausible traumatic injury event reported by the patient
- At least one clinical sign of brain injury such as loss of consciousness, altered mental status, posttraumatic amnesia, or neurological abnormality
- At least two acute symptoms like confusion, headache, nausea, vomiting, dizziness, vision problems, memory problems, emotional lability, or irritability
- Glasgow Coma Scale (GCS) score between 13 and 15 at least 30 minutes after injury
- Blood sample obtained within 12 hours after injury, ideally before any imaging
You will not qualify if you...
- Glasgow Coma Scale (GCS) score between 3 and 12 on admission
- Age below 18 years
- Unknown time of injury
- More than 12 hours since injury
- Primary admission for non-traumatic neurological disorders (e.g., stroke, spontaneous intracranial hematoma)
- Penetrating head trauma
- Patient requiring mechanical ventilation from the trauma scene or prehospital care
- Inability to perform venipuncture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
Research Team
A
Alfonso Lagares, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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