A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Traumatic Brain Injury
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 1501
- Locations
- 16
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
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.
Time Frame: 12 hours post Traumatic Brain Injury (TBI)
2 x 5mL blood sample
Secondary Outcomes
- Determination the potential of the two biomarkers in predicting neurological outcome(3 month after 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(7 days after traumatic brain injury (TBI))
- Determination of the potential of the two biomarkers in predicting neurological outcome(3 month after TBI)