Biomarker-guided care for mild traumatic brain injury using GFAP and UCH-L1
BLOOD BIOMARKERS TO IMPROVE MANAGEMENT OF MILD TRAUMATIC BRAIN INJURY IMPLIMENTACIÓN STUDY
This project will try a blood test that measures GFAP and UCH-L1 to see if adults with recent mild traumatic brain injury can safely avoid a head CT.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT07311486 on ClinicalTrials.gov |
What this trial studies
This ambispective cohort study at Hospital Universitario 12 de Octubre implements a clinical pathway using the VIDAS TBI blood assay (GFAP and UCH-L1) within 12 hours of injury to guide CT decisions for mild TBI. Patients managed under the new biomarker-based pathway will be compared to a historical six-month cohort treated before the pathway was introduced. Key outcomes are diagnostic performance for ruling out CT need, safety (missed intracranial injuries or neurological deterioration), and operational impact such as CT use and emergency department length of stay. Blood samples are obtained before imaging and predefined biomarker thresholds are applied as part of routine ER care.
Who should consider this trial
Good fit: Adults (age 18+) who present to the ER within 12 hours of a plausible head injury with GCS 13–15 and clinical signs or symptoms of mild TBI, and who can provide a blood sample before imaging.
Not a fit: Patients with moderate or severe TBI (GCS ≤12), children, those with unknown or >12-hour time since injury, or those needing immediate imaging are unlikely to benefit from this pathway.
Why it matters
Potential benefit: If successful, it could safely reduce unnecessary head CT scans and shorten emergency department stays for people with mild TBI.
How similar studies have performed: Previous work using GFAP and UCH-L1 has shown promise and supported regulatory clearance of similar biomarker tests, though real-world implementation in ER pathways remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Madrid, Madrid
- Hospital Universitario 12 de Octubre — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Alfonso Lagares, MD, PhD — Hospital Universitario 12 de Octubre
- Study coordinator: Alfonso Lagares, MD, PhD
- Email: alfonlag@ucm.es
- Phone: +34913908000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.