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.
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 Type
OBSERVATIONAL
Enrollment
1,500
measurment of UCH-L1 GFAP within 12 hours in adult patients after a mild traumatic brain injury
Centre Hospitalier Universitaire d'Angers
Angers, France
RECRUITINGHôpital Gabriel-Montpied - CHU de Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGHôpital François Mitterrand - CHU de Dijon
Dijon, France
RECRUITINGHôpital Nord - CHU de Grenoble-Alpes
Grenoble, France
RECRUITINGHospices Civils de Lyon
Lyon, France
RECRUITINGHôpital Lapeyronie - CHU de Montpellier
Montpellier, France
NOT_YET_RECRUITINGHôtel Dieu - CHU de Nantes
Nantes, France
RECRUITINGHôpital Pasteur CHU de Nice
Nice, France
RECRUITINGHôpital Carémeau - CHU de Nîmes
Nîmes, France
RECRUITINGAP-HP Nord Lariboisière
Paris, France
RECRUITING...and 5 more locations
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
Time frame: during the first 12 hours
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
Time frame: 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 .
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)
Percentage of intracranial complication identified by UCH-L1 and GFAP, alone or in combination, versus PS100b within the first 12 hours following a MTBI .
Time frame: 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
Time frame: 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.
Time frame: during the first 7 days
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