GFAP and UCH-L1
Diagnostic Test2x5mL blood samples will be used to determine the performance of the automated VIDAS TBI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.
NCT Number: NCT05425251
Mild traumatic brain injury (mTBI) is one of the most frequent emergencies in the elderly population. Despite most mTBI are managed with cranial computed tomography (CT), only 10% of CTs show lesions, determining CT overuse. The use of serum glial fibrillary acidic protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) have shown potential for ruling out the need for cranial CT. However evidence on biomarker use in mild TBI were not based on studies that included aged participants and patients with comorbidities for which biomarker levels could vary. This is why there is a need for a prospective study that assesses the predictive performance of these two biomarkers in the elderly population, both in elderly patients suffering mild TBI and in a reference population, including patients and participants with and without comorbidities.
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Notify Me65 year and older
All sexes
Observational
CHU Clermont-Ferrand, Clermont-Ferrand, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2x5mL blood samples will be used to determine the performance of the automated VIDAS TBI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.
Time frame: 12 hours after mild TBI
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1 used separately and in combination to detect the presence or absence of intracranial lesions on CT scan
Time frame: 1 week and 3 months
Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Neurological status at 1 week and 3 months after TBI and Rivermead post concussion questionnaire.
Time frame: 1 Day, day of extraction of the sample
GFAP serum level distribution in the non-TBI reference population, considering age and comorbidities.
Time frame: 1 Day, day of extraction of the sample
UCHL-1 serum level distribution in the non-TBI reference population, considering age and comorbidities.
Time frame: 1 week and 3 months
Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Extended Glasgow Outcome Score (GOSE)
Time frame: 1 week and 3 months
Early and midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by Qolibri-OS
Time frame: 3 months
Midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by EQ-5D-5L
Time frame: 3 months
Midterm biomarker predictive performance in terms of predicting depression symptoms after mild TBI assessed by PHQ-9
Hospital Universitario 12 de Octubre
Other
Blood Biomarkers to Improve Management of Mild Traumatic BRAIN Injury in the Elderly
Acronym: BRAINI2ELDER
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