Evaluating biomarkers for mild traumatic brain injury in elderly patients

Blood Biomarkers to Improve Management of Mild Traumatic BRAIN Injury in the Elderly

This study is testing if certain blood markers can help doctors decide if older patients with mild brain injuries need a CT scan.

Quick facts

• Study type: Observational
• Enrollment: 2850 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Hospital Universitario 12 de Octubre (Academic / other)
• Locations: 7 sites (Clermont-Ferrand and 6 other locations)
• Trial ID: NCT05425251 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the predictive performance of serum biomarkers GFAP and UCH-L1 in elderly patients with mild traumatic brain injury (mTBI). It will involve patients aged 65 and older who present with mTBI and require a cranial CT scan, as well as a reference group of non-TBI patients of the same age. Blood samples will be collected within 12 hours of injury to analyze the biomarkers' effectiveness in ruling out the need for CT scans. The study addresses the gap in existing research regarding the use of these biomarkers specifically in the elderly population, who often have comorbidities that may affect biomarker levels.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 65 and older who have sustained a mild TBI and require a CT scan.

Not a fit: Patients under 65 years of age or those with severe TBI or other neurological disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could reduce unnecessary CT scans in elderly patients with mild TBI, minimizing radiation exposure and healthcare costs.

How similar studies have performed: While the use of biomarkers in mTBI has been explored, this specific focus on elderly patients and their unique comorbidities represents a novel approach.

Eligibility criteria

Inclusion Criteria:

* BRAINI2-ELDERLY DIAGNOSTIC \& PROGNOSTIC:

  * Patients ≥65 years of age
  * Mild TBI (GCS 13-15 on admission) with indication of brain CT scan in the 12 hours after injury ;
  * Blood sample obtained ≤12 h after injury and CT scan preferably ≤6h from blood sample.
* BRAINI2-ELDERLY REFERENCE:

  * Non TBI patients ≥65 years of age

Exclusion Criteria:

* BRAINI2-ELDERLY DIAGNOSTIC \& PROGNOSTIC:

  * Age below 65 years.
  * GCS 3-12 on admission
  * 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
  * No realization of brain CT-scan
  * Subject under judiciary control
  * Subject in inclusion period of a drug interventional study
* BRAINI2-ELDERLY REFERENCE:

  * Subject in inclusion period of another drug interventional study
  * Patients harboring a brain tumor
  * Patients that have had a stroke or neurosurgical operation 1 month prior to the inclusion in the study.

Where this trial is running

Clermont-Ferrand and 6 other locations

• CHU Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
• CHU Grenoble-Alpes — Grenoble, France (Recruiting)
• Hôpital Edouard HERRIOT — Lyon, France (Recruiting)
• Hôpital Lyon Sud HCL — Lyon, France (Recruiting)
• Klinikum rechts der Isar — Munich, Germany (Recruiting)
• Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
• Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)

Study contacts

• Principal investigator: Alfonso Lagares Gómez-Abascal, MD, PhD — Hospital Universitario 12 de Octubre
• Study coordinator: Alfonso Lagares Gómez-Abascal, MD, PhD

Conditions Mild Traumatic Brain Injury