Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries

NCT05885529 | Recruiting

• 1 other identifier: 22-22
• Study Type: observational
• Target: 1,500
• Locations: 2 countries
• Sites: 15

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.

Conditions

Traumatic Brain Injury

Keywords

UCHL1; GFAP; CT scan

Outcome Measures

Primary Outcomes (1)

• performance of UCH-L1 and GFAP combined to rule out intracranial complication after MTBI

  Percentage of intracranial lesion excluded by UCH-L1 and GFAP combined, versus the CT scan, within the first 12 hours following a MTBI

  during the first 12 hours

Secondary Outcomes (5)

• Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI

  during the first 12 hours

• Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI

  during the first 12 hours with a focus every 3 hours

• Comparation of UCH-L1 and GFAP combined or alone, to S100b protein (PS100b)

  during the first 12 hours with a focus every 3 hours

• Predicted impact of using UCH-L1 and GFAP combined

  day 7

• Performance of UCHL-1 and GFAP alone or combined to predict complications

  during the first 7 days

Other Outcomes (1)

• ancillary outcome

  Day 1

Study Arms (1)

consecutive participants in the 15 centers

adult patients with mild traumatic brain injury admitted within 12 hours after the trauma. No interventions, observational study

Other: UCH-L1 GFAP

Interventions

UCH-L1 GFAP OTHER

measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury

consecutive participants in the 15 centers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Princesse Grace: lead
• BioMérieux: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• Hospices Civils de Lyon: collaborator
• Poitiers University Hospital: collaborator
• University Hospital, Angers: collaborator
• Centre Hospitalier Universitaire de Nīmes: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• Nantes University Hospital: collaborator
• University Hospital, Montpellier: collaborator
• Centre Hospitalier Universitaire Dijon: collaborator
• University Hospital, Grenoble: collaborator
• Fondation Hôpital Saint-Joseph: collaborator
• CHU de Tours: collaborator

Study Sites (15)

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample obtained at initial presentation

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Pierre HAUSFATER, MD-PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Yann-Erick CLAESSENS, MD-PhD

CONTACT

97 98 99 00; yann-erick.claessens@chpg.mc

Nicolas RIJO, CRA

CONTACT

97 98 99 00; recherche.clinique@chpg.mc

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 2, 2023
• Study Start: April 19, 2024
• Primary Completion: December 15, 2025
• Study Completion: March 30, 2026
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14); MO (1)