Improving diagnosis and outcome prediction in mild traumatic brain injury
Nuevos Biomarcadores y Tecnologia Para Una Mejores Reglas de predicción en el Traumatismo craneoncefálico Leve
This study is trying to find new ways to diagnose and predict recovery for people with mild traumatic brain injuries by looking at blood and saliva samples taken soon after their injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT06327776 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with mild traumatic brain injury (mTBI) to assess long-term outcomes and develop new prognostic models using serum and saliva biomarkers. By analyzing these biological samples collected within 24 hours of injury, the study aims to identify protein biomarkers that can improve diagnosis and predict recovery trajectories. The study includes a diverse patient population without excluding individuals based on comorbidities, allowing for a comprehensive understanding of mTBI outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have experienced a mild TBI with a Glasgow Coma Scale score of 13-15 and can provide a blood sample within 24 hours of injury.
Not a fit: Patients with more severe brain injuries (GCS 3-12), those with unknown injury times, or those with non-traumatic neurological disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic tools and personalized treatment plans for patients with mild traumatic brain injury.
How similar studies have performed: While there have been studies exploring biomarkers in traumatic brain injury, this specific approach focusing on mild TBI and the use of serum and saliva biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mild TBI (GCS 13-15 on admission) * Blood sample obtained ≤24h after injury Exclusion Criteria: * GCS 3-12 on admission * Time of injury unknown * Time to injury exceeding 24 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 * Subject under judiciary control
Where this trial is running
Madrid
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Alfonso Lagares, MD, PhD
- Email: alfonso.lagares@salud.madrid.org
- Phone: +34917792839
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.