Biomarker-guided care for mild traumatic brain injury using GFAP and UCH-L1

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.