Clinical trial NCT05885529: Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Keywords: UCHL1
GFAP
CT scan
Lead sponsor: Centre Hospitalier Princesse Grace
Sponsor class: OTHER
Collaborators: name: BioMérieux
name: Assistance Publique - Hôpitaux de Paris
name: University Hospital, Clermont-Ferrand
name: Hospices Civils de Lyon
name: Poitiers University Hospital
name: University Hospital, Angers
name: Centre Hospitalier Universitaire de Nīmes
name: Centre Hospitalier Universitaire de Nice
name: Nantes University Hospital
name: University Hospital, Montpellier
name: Centre Hospitalier Universitaire Dijon
name: University Hospital, Grenoble
name: Fondation Hôpital Saint-Joseph
name: CHU de Tours
First posted: 2023-06-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects consulting in the emergency department within 12 hours following a mild traumatic brain injury at risk of complications meeting the inclusion and exclusion criteria listed in the protocol.

Brief summary: The goal of this observational study is to evaluate the performance of UCH-L1 and GFAP combined in patients with a mild traumatic brain injury. The main question :

• Does the combination of UCH-L1 and GFAP can exclude brain injuries detected with CT scan in the first twelve hours after a mild traumatic brain injury?

Participants will do the exams planed in routine care and :

* during the expected blood sampling an additional blood sample will be done,
* seven days after the discharge a call will be done by the investigator.

Detailed description: Main study

The main study includes subjects presenting to the emergency department within 12 hours of mild traumatic brain injury with an intermediate risk of clinical worsening or intracranial lesions.

The participants have at least one of the following characteristics, as defined in the French recommendations

* \> 65 years treated with anti-platelet agents
* Glasgow Score \< 15 at 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

The study includes clinical sites in France and Monaco. Participants have a blood sample and a brain scan as part of the care. The participation of subjects in the study will not influence their treatment.

Ancillary study The ancillary study uses qualitative research methodology to assess acceptance by physicians and patients of a biological test rather than a CT scan to exclude intracranial complication after mild traumatic brain injury.

The study will takes place in the emergency department of the Nice University Hospital Center (CHU of Nice). It will include 30 subjects: 15 subjects presenting to the emergency room for mild traumatic brain injury and included in the main protocol and 15 prescribing emergency physicians.

The participation of subjects in the study will not influence their treatment.

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

Primary outcomes:
measure: performance of UCH-L1 and GFAP combined to rule out intracranial complication after MTBI
timeFrame: during the first 12 hours
Secondary outcomes:
measure: Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI
timeFrame: during the first 12 hours
measure: Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI
timeFrame: during the first 12 hours with a focus every 3 hours
measure: Comparation of UCH-L1 and GFAP combined or alone, to S100b protein (PS100b)
timeFrame: during the first 12 hours with a focus every 3 hours
measure: Predicted impact of using UCH-L1 and GFAP combined
timeFrame: day 7
measure: Performance of UCHL-1 and GFAP alone or combined to predict complications
timeFrame: during the first 7 days
Other outcomes:
measure: ancillary outcome
timeFrame: Day 1
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Clermont-Ferrand
country: France
facility: Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand
city: Dijon
country: France
facility: Hôpital François Mitterrand - CHU de Dijon
city: Grenoble
country: France
facility: Hôpital Nord - CHU de Grenoble-Alpes
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Montpellier
country: France
facility: Hôpital Lapeyronie - CHU de Montpellier
city: Nantes
country: France
facility: Hôtel Dieu - CHU de Nantes
city: Nice
country: France
facility: Hôpital Pasteur CHU de Nice
city: Nîmes
country: France
facility: Hôpital Carémeau - CHU de Nîmes
city: Paris
country: France
facility: AP-HP Nord Lariboisière
city: Paris
country: France
facility: AP-HP Sorbonne Université, site Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Saint-Joseph
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Tours
country: France
facility: Hôpital Trousseau - CHRU Tours
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pierre HAUSFATER, MD-PhD
role: STUDY_DIRECTOR
References: