Evaluating blood tests to rule out brain injuries after mild trauma

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Hôtel Dieu - CHU de Nantes
  Nantes, France Recruiting

Study contacts

• Study coordinator: Yann-Erick CLAESSENS, MD-PhD
• Email: yann-erick.claessens@chpg.mc
• Phone: 97 98 99 00

Similar studies

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

• PIONEER-Prognosis: Using biomarkers and wearables to forecast recovery after mild traumatic brain injury

  This study tests whether blood biomarkers, health data from records, and wearables can help predict how people recover after a mild traumatic brain injury treated in the emergency department.

  Recruiting at 3 sites University of Michigan · Torrance, California and 4 other locations · NCT07858266

• HBOT to see if it helps cognition and well‑being in first responders with prior brain injury

  This study tests whether 40 hyperbaric oxygen therapy sessions can improve thinking skills and post-concussion symptoms in current or former first responders with a history of brain injury.

  Recruiting Phase 2 Summit Hyperbarics and Wellness · Boise, Idaho · NCT07852728

• Depth Electrode Monitoring after Traumatic Brain Injury

  This study tests adding a depth electrode with continuous brain monitoring during external ventricular drain placement in adults with traumatic brain injury to see if cortical reverberation signals can be tracked safely.

  Recruiting Hennepin Healthcare Research Institute · Minneapolis, Minnesota · NCT07842458

• Understanding growth hormone deficiency after a brain injury in adults

  This observational study tests whether growth hormone deficiency affects quality of life and symptoms in adults with traumatic brain injury and whether GH replacement helps after 12 weeks.

  Recruiting University of Calgary · Calgary, Alberta and 1 other locations · NCT07795736

• Electrical stimulation-assisted exercise for people with lower limb paralysis

  This study tests whether adding electrical stimulation during exercise can improve leg muscle strength and endurance for people with paralysis.

  Recruiting Louis Stokes VA Medical Center · Cleveland, Ohio · NCT07768761

• ZEPU-2000 robotic rehab for arm and leg weakness

  This trial tests whether adding ZEPU-2000A, ZEPU-2000D, and ZEPU-2000E robotic rehabilitation to usual therapy helps adults with arm/leg movement problems from stroke, incomplete SCI, TBI, or related conditions.

  Recruiting Bangladesh Medical University · Dhaka · NCT07749612

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.