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NCT Number: NCT05885529

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire d'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UCH-L1 GFAP

Other

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

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: during the first 12 hours

    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

  2. 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

    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 .

  3. 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

    Percentage of intracranial complication identified by UCH-L1 and GFAP, alone or in combination, versus PS100b within the first 12 hours following a MTBI .

  4. Predicted impact of using UCH-L1 and GFAP combined

    Time frame: day 7

    Variation of resource consumption by the use of UCH-L1 and GFAP

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

    Time frame: during the first 7 days

    Percentage of complications avoided by the use of UCH-L1 and GFAP, alone or combined.

Other outcomes

  1. ancillary outcome

    Time frame: Day 1

    Acceptability by a semi-directed interview of a new strategy integrating the use of biomarkers for the management of MTBI by patients and investigators

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas RIJO, CRA

CONTACT

[email protected]

97 98 99 00 ext. +377

Yann-Erick CLAESSENS, MD-PhD

CONTACT

[email protected]

97 98 99 00 ext. +377

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Princesse Grace

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • BioMérieux
  • CHU de Tours
  • Centre Hospitalier Universitaire Dijon
  • Centre Hospitalier Universitaire de Nice
  • Centre Hospitalier Universitaire de Nīmes
  • 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

Registry information

Official study 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

Acronym: GUEST

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 2, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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