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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: UCH-L1 GFAP

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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Yann-Erick CLAESSENS, MD-PhD; Phone Number: +377 97 98 99 00; Email: yann-erick.claessens@chpg.mc
• Study Contact Backup: Name: Nicolas RIJO, CRA; Phone Number: +377 97 98 99 00; Email: recherche.clinique@chpg.mc

Study Locations

• France
  • Angers, France
    • Centre Hospitalier Universitaire d'Angers
    • Contact: Delphine DOUILLET, MD
  • Clermont-Ferrand, France
    • Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand
    • Contact: Jeannot SCHMIDT, MD-PhD
  • Dijon, France
    • Hôpital François Mitterrand - CHU de Dijon
    • Contact: Patrick RAY, MD-PhD
  • Grenoble, France
    • Hôpital Nord - CHU de Grenoble-Alpes
    • Contact: Damien VIGLINO, MD-PhD
  • Lyon, France
    • Hospices Civils de Lyon
    • Contact: Laurent JACQUIN, MD
  • Montpellier, France
    • Hôpital Lapeyronie - CHU de Montpellier
    • Contact: Xavier BOBBIA, MD-PhD
  • Nantes, France
    • Hôtel Dieu - CHU de Nantes
    • Contact: Emmanuel MONTASSIER, MD-PhD
  • Nice, France
    • Hôpital Pasteur CHU de Nice
    • Contact: Céline OCCELI, MD
  • Nîmes, France
    • Hôpital Carémeau - CHU de Nîmes
    • Contact: Pierre-Géraut CLARET, MD-PhD
  • Paris, France
    • Hôpital Saint-Joseph
    • Contact: Camille GERLIER, MD
  • Paris, France
    • AP-HP Nord Lariboisière
    • Contact: Anthony CHAUVIN, MD
  • Paris, France
    • AP-HP Sorbonne Université, site Pitié-Salpêtrière
    • Contact: Pierre HAUSFATER, MD-PhD
  • Poitiers, France
    • Centre Hospitalier Universitaire de Poitiers
    • Contact: Jérémy GUENEZAN, MD
  • Tours, France
    • Hôpital Trousseau - CHRU Tours
    • Contact: Said LARIBI, MD-PhD
• Monaco
  • Monaco, Monaco
    • Centre Hospitalier Princesse Grace
    • Contact: Yann-Erick CLAESSENS, MD-PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI	Percentage of intracranial bleeding excluded by UCH-L1 and GFAP alone or combined, versus the CT scan, within the first 12 hours following a MTBI	during the first 12 hours
Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI	Percentage of intracranial lesion excluded by UCH-L1 and GFAP alone or combined, versus the CT scan, within the first 12 hours following a 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)	Percentage of intracranial complication identified by UCH-L1 and GFAP, alone or in combination, versus PS100b within the first 12 hours following a MTBI .	during the first 12 hours with a focus every 3 hours
Predicted impact of using UCH-L1 and GFAP combined	Variation of resource consumption by the use of UCH-L1 and GFAP	day 7
Performance of UCHL-1 and GFAP alone or combined to predict complications	Percentage of complications avoided by the use of UCH-L1 and GFAP, alone or combined.	during the first 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ancillary outcome	Acceptability by a semi-directed interview of a new strategy integrating the use of biomarkers for the management of MTBI by patients and investigators	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Princesse Grace
• Collaborators: Assistance Publique - Hôpitaux de Paris; Hospices Civils de Lyon; University Hospital, Angers; Centre Hospitalier Universitaire Dijon; University Hospital, Montpellier; Poitiers University Hospital; University Hospital, Clermont-Ferrand; Centre Hospitalier Universitaire de Nice; Centre Hospitalier Universitaire de Nīmes; University Hospital, Grenoble; Nantes University Hospital; BioMérieux; CHU de Tours; Fondation Hôpital Saint-Joseph
• Investigators: Study Director: Pierre HAUSFATER, MD-PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: CT scan; GFAP; UCHL1
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 22-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No