Traumatic Brain InjuryGUESTNCT05885529
Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries
An observational study of Traumatic Brain Injury, run by Centre Hospitalier Princesse Grace at 15 sites in 2 countries.
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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- UCH-L1 GFAP
- How many people
- 1,500 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 19 Apr 2024to 30 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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,
Show all 12Show fewer
- 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
Who cannot join
- 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),
Show all 13Show fewer
- 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
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
France14 sites, 14 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Angers
Angers
Delphine DOUILLET, MD
- Recruiting
Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand
Clermont-Ferrand
Jeannot SCHMIDT, MD-PhD
- Recruiting
Hôpital François Mitterrand - CHU de Dijon
Dijon
Patrick RAY, MD-PhD
- Recruiting
Hôpital Nord - CHU de Grenoble-Alpes
Grenoble
Damien VIGLINO, MD-PhD
- Recruiting
Hospices Civils de Lyon
Lyon
Laurent JACQUIN, MD
- Not yet recruiting
Hôpital Lapeyronie - CHU de Montpellier
Montpellier
Xavier BOBBIA, MD-PhD
- Recruiting
Hôtel Dieu - CHU de Nantes
Nantes
Emmanuel MONTASSIER, MD-PhD
- Recruiting
Hôpital Pasteur CHU de Nice
Nice
Céline OCCELI, MD
- Recruiting
Hôpital Carémeau - CHU de Nîmes
Nîmes
Pierre-Géraut CLARET, MD-PhD
- Recruiting
AP-HP Nord Lariboisière
Paris
Anthony CHAUVIN, MD
- Recruiting
AP-HP Sorbonne Université, site Pitié-Salpêtrière
Paris
Pierre HAUSFATER, MD-PhD
- Recruiting
Hôpital Saint-Joseph
Paris
Camille GERLIER, MD
- Recruiting
Centre Hospitalier Universitaire de Poitiers
Poitiers
Jérémy GUENEZAN, MD
- Recruiting
Hôpital Trousseau - CHRU Tours
Tours
Said LARIBI, MD-PhD
Monaco1 site, 1 recruiting
- Recruiting
Centre Hospitalier Princesse Grace
Monaco
Yann-Erick CLAESSENS, MD-PhD
About this study
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
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- UCH-L1 GFAP
- Keywords
- UCHL1, GFAP, CT scan
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCH-L1 GFAPOther
measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury
| Study group | Role | What they receive |
|---|---|---|
| consecutive participants in the 15 centers | adult patients with mild traumatic brain injury admitted within 12 hours after the trauma. No interventions, observational study Receives: Other: UCH-L1 GFAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the first 12 hours
Secondary outcomes (5)
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
Measured: 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 .
Measured: 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 .
Measured: 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
Measured: 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.
Measured: during the first 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start19 Apr 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux, Assistance Publique - Hôpitaux de Paris, University Hospital, Clermont-Ferrand, Hospices Civils de Lyon, Poitiers University Hospital, University Hospital, Angers, Centre Hospitalier Universitaire de Nīmes, Centre Hospitalier Universitaire de Nice, Nantes University Hospital, University Hospital, Montpellier, Centre Hospitalier Universitaire Dijon, University Hospital, Grenoble, Fondation Hôpital Saint-Joseph, CHU de Tours
- Responsible party
- Sponsor
- Investigators
- Pierre HAUSFATER, MD-PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885529
- Sponsor's protocol ID
- 22-22
- Acronym
- GUEST
- Status last verified
- Feb 2025
- First submitted
- 4 May 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05885529
- Acronym / sponsor ID
- GUEST / 22-22
- Conditions
- Traumatic Brain Injury
- Keywords
- UCHL1, GFAP, CT scan
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Collaborators
- BioMérieux, Assistance Publique - Hôpitaux de Paris, University Hospital, Clermont-Ferrand, Hospices Civils de Lyon, Poitiers University Hospital, University Hospital, Angers, Centre Hospitalier Universitaire de Nīmes, Centre Hospitalier Universitaire de Nice, Nantes University Hospital, University Hospital, Montpellier, Centre Hospitalier Universitaire Dijon, University Hospital, Grenoble, Fondation Hôpital Saint-Joseph, CHU de Tours
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| consecutive participants in the 15 centers | – | Other: UCH-L1 GFAPadult patients with mild traumatic brain injury admitted within 12 hours after the trauma. No interventions, observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Traumatic brain injury defined by
- Glasgow Coma Scal 13, 14 or 15
- One of the following 4 criteria:
- 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
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCH-L1 GFAPmeasurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury | Other | consecutive participants in the 15 centers |
Primary outcome
performance of UCH-L1 and GFAP combined to rule out intracranial complication after MTBI
Time frame: during the first 12 hours
Percentage of intracranial lesion excluded by UCH-L1 and GFAP combined, versus the CT scan, within the first 12 hours following a MTBI
5 secondary outcomes
Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI
Time frame: during the first 12 hours
Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI
Time frame: during the first 12 hours with a focus every 3 hours
Comparation of UCH-L1 and GFAP combined or alone, to S100b protein (PS100b)
Time frame: during the first 12 hours with a focus every 3 hours
Predicted impact of using UCH-L1 and GFAP combined
Time frame: day 7
Performance of UCHL-1 and GFAP alone or combined to predict complications
Time frame: during the first 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre HAUSFATER, MD-PhD study director
Assistance Publique - Hôpitaux de Paris
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Centre Hospitalier Princesse Grace at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yann-Erick CLAESSENS, MD-PhD (97 98 99 00 ext. +377, yann-erick.claessens@chpg.mc), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
performance of UCH-L1 and GFAP combined to rule out intracranial complication after MTBI (time frame: during the first 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.