GFAP and UCH-L1: Serum test to measure the concentration of GFAP and UCH-L1
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* -All adult patients suffering mild TBI:( Defined by at least criterion a) and d) and one or more of the other criteria)
1. The presence of a plausible traumatic mechanism observed/or related by the patient´s recount of the injury event.
2. 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.
3. 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.
4. 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 Criteria:
* · 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
Primary outcome measure(s)
Diagnostic performance of the biomarker test — 12 hours after mild TBI Sensitivity, specificity and NPV of the combined biomarker test to determine the presence of lesions on CT
Proportion (%) of CT scan prescribed in the ER over the period of the study for patients with mTBI — 12 hours after mild TBI Proportion of patients in whom a CT scan has been performed for screening of intracranial lesiones
Trial sites (1)
Facility
City
Region
Status
Hospital Universitario 12 de Octubre
Madrid
Madrid
Recruiting
More Hospital Universitario 12 de Octubre trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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