Mild Traumatic Brain Injury
Conditions
Brief summary
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.
Interventions
OTHER2 x 5 mL blood sample
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.
Sponsors
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 hours post Traumatic Brain Injury (TBI) | 2 x 5mL blood sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the potential of the two biomarkers in predicting neurological outcome | 3 month after TBI | Quality of life after brain injury (QOLIBRI) Questionnaire) |
| 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 | Admission | TCD measures at admission |
| Determination the potential of the two biomarkers in predicting neurological outcome | 3 month after TBI | Extended Glasgow Outcome Scale (GOSE) |
Countries
France, Spain
Outcome results
None listed