GUEST: Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) to Exclude Lesions Linked to Significant Traumatic Brain Injuries
Study Details
Study Description
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 :
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during the expected blood sampling an additional blood sample will be done,
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seven days after the discharge a call will be done by the investigator.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
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65 years treated with anti-platelet agents
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Glasgow Score < 15 at two hours after the trauma if associated intoxication (alcohol, narcotic, psychotropic)
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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.),
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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
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- performance of UCH-L1 and GFAP combined to rule out intracranial complication after MTBI [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 Outcome Measures
- Performance of UCH-L1 and GFAP combined to rule out intracranial bleeding after MTBI [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
- 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]
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 .
- Comparation of UCH-L1 and GFAP combined or alone, to S100b protein (PS100b) [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 .
- Predicted impact of using UCH-L1 and GFAP combined [day 7]
Variation of resource consumption by the use of UCH-L1 and GFAP
- Performance of UCHL-1 and GFAP alone or combined to predict complications [during the first 7 days]
Percentage of complications avoided by the use of UCH-L1 and GFAP, alone or combined.
Other Outcome Measures
- ancillary outcome [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Traumatic brain injury defined by
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Impact on the skull or the face AND OR
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Acceleration / deceleration
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Glasgow Coma Scal 13, 14 or 15
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One of the following 4 criteria:
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65 years treated with anti-platelet agent,
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GCS < 15 two hours after the trauma if associated intoxication (alcohol, narcotic, psychotropic),
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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.),
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Amnesia of facts > 30 min before the trauma.
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Having a blood sample taken as part of care with a delay between the clinical event and the biological sample < 12 hours
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Having a CT-scan prescription as part of the MTBI evaluation
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Patient who signed an informed consent form
Exclusion Criteria:
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Person not affiliated or not benefiting from a health insurance scheme.
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Person under judicial protection.
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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
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Blood collection time > 12 hours
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Subjects for which a scan would be carried out systematically, including:
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GCS <13 (moderate or severe trauma),
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congenital hemostasis disorders or patient on anti-coagulant treatment,
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clinical signs evoking a fracture of the vault or the base of the skull,
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more than one episode of vomiting,
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post-traumatic convulsion,
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focal neurological deficit.
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Obstacle to follow-up at D7
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Malignant melanomas
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire d'Angers | Angers | France | ||
| 2 | Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand | Clermont-Ferrand | France | ||
| 3 | Hôpital François Mitterrand - CHU de Dijon | Dijon | France | ||
| 4 | Hôpital Nord - CHU de Grenoble-Alpes | Grenoble | France | ||
| 5 | Hospices Civils de Lyon | Lyon | France | ||
| 6 | Hôpital Lapeyronie - CHU de Montpellier | Montpellier | France | ||
| 7 | Hôtel Dieu - CHU de Nantes | Nantes | France | ||
| 8 | Hôpital Pasteur CHU de Nice | Nice | France | ||
| 9 | Hôpital Carémeau - CHU de Nîmes | Nîmes | France | ||
| 10 | AP-HP Nord Lariboisière | Paris | France | ||
| 11 | AP-HP Sorbonne Université, site Pitié-Salpêtrière | Paris | France | ||
| 12 | Hôpital Saint-Joseph | Paris | France | ||
| 13 | Centre Hospitalier Universitaire de Poitiers | Poitiers | France | ||
| 14 | Hôpital Trousseau - CHRU Tours | Tours | France | ||
| 15 | Centre Hospitalier Princesse Grace | Monaco | Monaco |
Sponsors and Collaborators
- Centre Hospitalier Princesse Grace
- 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
- CHU de Nantes
- University Hospital, Montpellier
- Centre Hospitalier Universitaire Dijon
- University Hospital, Grenoble
- Fondation Hôpital Saint Joseph
- CHU de Tours
Investigators
- Study Director: Pierre HAUSFATER, MD-PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-22