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| Name | Class |
|---|---|
| BioMérieux | INDUSTRY |
| Assistance Publique - Hôpitaux de Paris | OTHER |
| University Hospital, Clermont-Ferrand | OTHER |
| Hospices Civils de Lyon |
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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 :
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| consecutive participants in the 15 centers | adult patients with mild traumatic brain injury admitted within 12 hours after the trauma. No interventions, observational study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCH-L1 GFAP | Other | measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
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
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:
Obstacle to follow-up at D7
Malignant melanomas
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yann-Erick CLAESSENS, MD-PhD | Contact | 97 98 99 00 | +377 | yann-erick.claessens@chpg.mc |
| Nicolas RIJO, CRA | Contact | 97 98 99 00 | +377 | recherche.clinique@chpg.mc |
| Name | Affiliation | Role |
|---|---|---|
| Pierre HAUSFATER, MD-PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Angers | Recruiting | Angers | France |
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| OTHER |
| Poitiers University Hospital | OTHER |
| University Hospital, Angers | OTHER_GOV |
| Centre Hospitalier Universitaire de Nīmes | OTHER |
| Centre Hospitalier Universitaire de Nice | OTHER |
| Nantes University Hospital | OTHER |
| University Hospital, Montpellier | OTHER |
| Centre Hospitalier Universitaire Dijon | OTHER |
| University Hospital, Grenoble | OTHER |
| Fondation Hôpital Saint-Joseph | OTHER |
| CHU de Tours | UNKNOWN |
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blood sample obtained at initial presentation
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 |
| Hôpital Gabriel-Montpied - CHU de Clermont-Ferrand | Recruiting | Clermont-Ferrand | France |
|
| Hôpital François Mitterrand - CHU de Dijon | Recruiting | Dijon | France |
|
| Hôpital Nord - CHU de Grenoble-Alpes | Recruiting | Grenoble | France |
|
| Hospices Civils de Lyon | Recruiting | Lyon | France |
|
| Hôpital Lapeyronie - CHU de Montpellier | Not yet recruiting | Montpellier | France |
|
| Hôtel Dieu - CHU de Nantes | Recruiting | Nantes | France |
|
| Hôpital Pasteur CHU de Nice | Recruiting | Nice | France |
|
| Hôpital Carémeau - CHU de Nîmes | Recruiting | Nîmes | France |
|
| AP-HP Nord Lariboisière | Recruiting | Paris | France |
|
| AP-HP Sorbonne Université, site Pitié-Salpêtrière | Recruiting | Paris | France |
|
| Hôpital Saint-Joseph | Recruiting | Paris | France |
|
| Centre Hospitalier Universitaire de Poitiers | Recruiting | Poitiers | France |
|
| Hôpital Trousseau - CHRU Tours | Recruiting | Tours | France |
|
| Centre Hospitalier Princesse Grace | Recruiting | Monaco | Monaco |
|
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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