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

Traumatic Brain Injury Clinical Trial

— GUEST  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05885529
• Other study ID #: 22-22
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Princesse Grace
• Contact: Yann-Erick CLAESSENS, MD-PhD
• Phone: 97 98 99 00
• Email: yann-erick.claessens[@]chpg.mc
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: March 30, 2025
• Est. primary completion date: October 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	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
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (15)

Lead Sponsor

Collaborator

Centre Hospitalier Princesse Grace

Assistance Publique - Hôpitaux de Paris, BioMérieux, Centre Hospitalier Universitaire de Nice, Centre Hospitalier Universitaire de Nimes, Centre Hospitalier Universitaire Dijon, CHU de Tours, Fondation Hôpital Saint-Joseph, Hospices Civils de Lyon, Nantes University Hospital, Poitiers University Hospital, University Hospital, Angers, University Hospital, Clermont-Ferrand, University Hospital, Grenoble, University Hospital, Montpellier

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Predicted impact of using UCH-L1 and GFAP combined	Variation of resource consumption by the use of UCH-L1 and GFAP	day 7
Secondary	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