Evaluating blood tests to rule out brain injuries after mild trauma

Added Value, Performance and Acceptance of the "GFAP-UCH-L1" Pair in the Evaluation of Subjects with Mild Traumatic Brain Injury (MTBI) At Intermediate Risk of Complications

This study is testing if two blood tests can help doctors rule out serious brain injuries in people who have had a mild head injury.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Princesse Grace (Academic / other)
• Locations: 15 sites (Angers and 14 other locations)
• Trial ID: NCT05885529 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of two biomarkers, UCH-L1 and GFAP, in excluding significant brain injuries in patients who have experienced a mild traumatic brain injury (MTBI). Participants will be evaluated in the emergency department within 12 hours of their injury, and will undergo routine care including a CT scan and blood sampling. The study will also involve follow-up calls to participants seven days post-discharge to gather additional data. The goal is to determine if these biomarkers can serve as reliable indicators to avoid unnecessary imaging.

Who should consider this trial

Good fit: Ideal candidates include individuals over 65 on anti-platelet therapy, those with a Glasgow Coma Scale score of less than 15 due to intoxication, or patients with high-risk trauma mechanisms.

Not a fit: Patients with severe traumatic brain injuries or those not meeting the inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could reduce the need for CT scans in patients with mild traumatic brain injuries, minimizing radiation exposure and healthcare costs.

How similar studies have performed: While the approach of using biomarkers in this context is relatively novel, similar studies have shown promise in other areas of traumatic brain injury assessment.

Eligibility criteria

Inclusion Criteria:

* Traumatic brain injury defined by

  * Impact on the skull or the face AND OR
  * Acceleration / deceleration
* Glasgow Coma Scal 13, 14 or 15
* One of the following 4 criteria:

  * \> 65 years treated with anti-platelet agent,
  * GCS \< 15 two hours after the trauma if associated intoxication (alcohol, narcotic, psychotropic),
  * Trauma with high kinetics (for information only: a risk mechanism (pedestrian knocked down by a motorized vehicle, ejection from a vehicle, fall from more than 3 steps (more than one meter), etc.),
  * Amnesia of facts \> 30 min before the trauma.
* Having a blood sample taken as part of care with a delay between the clinical event and the biological sample \< 12 hours
* Having a CT-scan prescription as part of the MTBI evaluation
* Patient who signed an informed consent form

Exclusion Criteria:

* Person not affiliated or not benefiting from a health insurance scheme.
* Person under judicial protection.
* Person with restrictions of freedom or subject to Articles L.3212-1 and L.3213-1, and not included in Article L.1122-8 of the French CSP
* Blood collection time \> 12 hours
* Subjects for which a scan would be carried out systematically, including:

  * GCS \<13 (moderate or severe trauma),
  * congenital hemostasis disorders or patient on anti-coagulant treatment,
  * clinical signs evoking a fracture of the vault or the base of the skull,
  * more than one episode of vomiting,
  * post-traumatic convulsion,
  * focal neurological deficit.
* Obstacle to follow-up at D7
* Malignant melanomas

Where this trial is running

Angers and 14 other locations

• Centre Hospitalier Universitaire d'Angers — Angers, France (Recruiting)
• Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
• Hôpital François Mitterrand - CHU de Dijon — Dijon, France (Recruiting)
• Hôpital Nord - CHU de Grenoble-Alpes — Grenoble, France (Recruiting)
• Hospices Civils de Lyon — Lyon, France (Recruiting)
• Hôpital Lapeyronie - CHU de Montpellier — Montpellier, France (Not_yet_recruiting)
• Hôtel Dieu - CHU de Nantes — Nantes, France (Recruiting)
• Hôpital Pasteur CHU de Nice — Nice, France (Recruiting)
• Hôpital Carémeau - CHU de Nîmes — Nîmes, France (Recruiting)
• AP-HP Nord Lariboisière — Paris, France (Recruiting)
• AP-HP Sorbonne Université, site Pitié-Salpêtrière — Paris, France (Recruiting)
• Hôpital Saint-Joseph — Paris, France (Recruiting)
• Centre Hospitalier Universitaire de Poitiers — Poitiers, France (Recruiting)
• Hôpital Trousseau - CHRU Tours — Tours, France (Recruiting)
• Centre Hospitalier Princesse Grace — Monaco, Monaco (Recruiting)

Study contacts

• Study coordinator: Yann-Erick CLAESSENS, MD-PhD

Conditions Traumatic Brain Injury; UCHL1; GFAP; CT scan