A Study of Biomarkers of Mild Traumatic BRAIN Injury

Study Overview
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Brief Summary
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Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

Official Title
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A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury

Conditions
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Mild Traumatic Brain Injury

Intervention / Treatment
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* Other: 2 x 5 mL blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >18 years old (France) Mild TBI (GCS 13-15 on admission) within 12 hours after injury Indication of brain CT scan: neurological focal deficit anterograde amnesia Glasgow coma scale score <15 after 2 hours post-TBI suspicion of vault depression fracture fracture of the basal skull persisting nausea, vomiting or headache post-TBI seizures Pre-injury treatment with antithrombotic drugs Loss of consciousness or amnesia with age >65 years, fall >1m or hit pedestrian Other condition requiring CT scan according to the in-charge physician. Exclusion Criteria: GCS 3-12 on admission Time of injury unknown Time to injury exceeding 12 hours Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous intracranial hematoma) Penetrating head trauma Patient with mechanical ventilation Pre-injury neurological disorder affecting the assessment of neurological outcome: dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumor, and history of neurosurgery, stroke or transient ischemic attack (TIA) within the last 30 days Venipuncture not feasible No realization of brain CT-scan Subject under judiciary control Pregnant or breastfeeding woman Subject in exclusion period of another study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild TBI<br>Mild TBI (GCS 13-15 on admission) within 12 hours after injury | Other: 2 x 5 mL blood sample<br>* 2 x 5 mL blood sample to determine the performance of the automated VIDAS BTI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the VIDAS-BTI assay in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and their corresponding lower limit of 95% confidence interval by comparison with brain CT scan findings. | 2 x 5mL blood sample | 12 hours post Traumatic Brain Injury (TBI) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home | TCD measures at admission | Admission | 
| Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home | Neurological status at 1 week after TBI | 7 days after traumatic brain injury (TBI) | 
| Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home | Quality of life after brain injury (QOLIBRI) Questionnaire | 7 days after traumatic brain injury (TBI) | 
| Determination the potential of the two biomarkers in predicting neurological outcome | Extended Glasgow Outcome Scale (GOSE) | 3 month after TBI | 
| Determination of the potential of the two biomarkers in predicting neurological outcome | Quality of life after brain injury (QOLIBRI) Questionnaire) | 3 month after TBI | 
| Determination of the potential of the two biomarkers in predicting neurological outcome | EuroQuol 5 dimensions 5 level questionnaire (EQ-5D-5L) | 3 month after TBI | 
| Determination of the potential of the two biomarkers in predicting neurological outcome | Rivermead Post-concussion symptoms Questionnaire (RPQ) | 3 month after TBI |