Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries
NCT ID: NCT05885529
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2024-04-19
2026-03-30
Brief Summary
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• 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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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consecutive participants in the 15 centers
adult patients with mild traumatic brain injury admitted within 12 hours after the trauma. No interventions, observational study
UCH-L1 GFAP
measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury
Interventions
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UCH-L1 GFAP
measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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BioMérieux
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
University Hospital, Clermont-Ferrand
OTHER
Hospices Civils de Lyon
OTHER
Poitiers University Hospital
OTHER
University Hospital, Angers
OTHER_GOV
Centre Hospitalier Universitaire de Nīmes
OTHER
Centre Hospitalier Universitaire de Nice
OTHER
Nantes University Hospital
OTHER
University Hospital, Montpellier
OTHER
Centre Hospitalier Universitaire Dijon
OTHER
University Hospital, Grenoble
OTHER
Fondation Hôpital Saint-Joseph
OTHER
CHU de Tours
UNKNOWN
Centre Hospitalier Princesse Grace
OTHER
Responsible Party
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Principal Investigators
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Pierre HAUSFATER, MD-PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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Centre Hospitalier Universitaire d'Angers
Angers, , France
Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Hôpital François Mitterrand - CHU de Dijon
Dijon, , France
Hôpital Nord - CHU de Grenoble-Alpes
Grenoble, , France
Hospices Civils de Lyon
Lyon, , France
Hôpital Lapeyronie - CHU de Montpellier
Montpellier, , France
Hôtel Dieu - CHU de Nantes
Nantes, , France
Hôpital Pasteur CHU de Nice
Nice, , France
Hôpital Carémeau - CHU de Nîmes
Nîmes, , France
AP-HP Nord Lariboisière
Paris, , France
AP-HP Sorbonne Université, site Pitié-Salpêtrière
Paris, , France
Hôpital Saint-Joseph
Paris, , France
Centre Hospitalier Universitaire de Poitiers
Poitiers, , France
Hôpital Trousseau - CHRU Tours
Tours, , France
Centre Hospitalier Princesse Grace
Monaco, , Monaco
Countries
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Central Contacts
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Facility Contacts
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Delphine DOUILLET, MD
Role: primary
Jeannot SCHMIDT, MD-PhD
Role: primary
Patrick RAY, MD-PhD
Role: primary
Damien VIGLINO, MD-PhD
Role: primary
Laurent JACQUIN, MD
Role: primary
Xavier BOBBIA, MD-PhD
Role: primary
Emmanuel MONTASSIER, MD-PhD
Role: primary
Céline OCCELI, MD
Role: primary
Pierre-Géraut CLARET, MD-PhD
Role: primary
Anthony CHAUVIN, MD
Role: primary
Pierre HAUSFATER, MD-PhD
Role: primary
Camille GERLIER, MD
Role: primary
Jérémy GUENEZAN, MD
Role: primary
Said LARIBI, MD-PhD
Role: primary
Yann-Erick CLAESSENS, MD-PhD
Role: primary
Other Identifiers
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22-22
Identifier Type: -
Identifier Source: org_study_id
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