Evaluating biomarkers for mild traumatic brain injury in elderly patients

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Alfonso Lagares Gómez-Abascal, MD, PhD — Hospital Universitario 12 de Octubre
• Study coordinator: Alfonso Lagares Gómez-Abascal, MD, PhD
• Email: alfonso.lagares@salud.madrid.org
• Phone: +34917792839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Recovery after mild traumatic brain injury in older adults

  This project will follow people 65 and older who had a mild TBI to see how their thinking, physical abilities, mood, and sleep change over the year after injury.

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• TES HT100 screening for intracranial problems after mild head injury or new neurological symptoms

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• Cognitive behavioral therapy for insomnia in people with mild traumatic brain injury

  This study will try cognitive behavioral therapy for insomnia (CBT-I) to see if it helps adults with mild traumatic brain injury sleep better and improve daily functioning.

  Recruiting University of Missouri-Columbia · Columbia, Missouri · NCT07385105

• Passive neurosensory reintegration training to help recovery after mild traumatic brain injury

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• Early Intervention for Adults with Ongoing Post-Concussion Symptoms after Mild TBI

  This study tests a package of physical/occupational therapy and telephonic psychoeducation to help adults recover after a mild traumatic brain injury.

  Recruiting University Medical Center Groningen · Groningen · NCT07341074

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.