This study aims to evaluate the real-world applicability and clinical added value of a new management pathway for patients presenting to the emergency department (ER) with mild traumatic brain injury (mTBI). The pathway includes the use of the VIDAS® TBI in vitro diagnostic assay, which measures the blood biomarkers GFAP and UCH-L1 within 12 hours of injury to determine whether a CT scan is necessary.
The study seeks to answer two primary questions:
1. Safety and effectiveness: Whether the VIDAS® TBI test can safely and accurately rule out the need for head CT in mTBI patients in routine emergency care. 2. Clinical and operational impact: Whether incorporating this test reduces the number of CT scans performed and shortens ER length of stay for patients with mild TBI.
To assess these outcomes, researchers will compare patient management using the new biomarker-based pathway to a historical cohort of mTBI patients who were managed without the biomarker test.
-All adult patients suffering mild TBI:( Defined by at least criterion a) and d) and one or more of the other criteria)
The presence of a plausible traumatic mechanism observed/or related by the patient´s recount of the injury event.
Presence of one or more clinical signs attributable to brain injury: Loss of consciousness immediately following injury, alteration of mental status immediately following the injury, posttraumatic amnesia or any neurological abnormality.
At least two acute symptoms related to the injury: feeling confused or disoriented, headache, nausea, vomiting, dizziness, vision problems, memory problems, emotional lability or irritability.
· GCS 3-12 on admission
Age Below 18 years
Time of injury unknown
Time to injury exceeding 12 hours
Mild traumatic brain injured patients admitted in the ER less than 12 hours after injury
Cohort
Other
GFAP and UCH-L1
Diagnostic testSerum test to measure the concentration of GFAP and UCH-L1
Diagnostic performance of the biomarker test
Sensitivity, specificity and NPV of the combined biomarker test to determine the presence of lesions on CT
Proportion (%) of CT scan prescribed in the ER over the period of the study for patients with mTBI
Proportion of patients in whom a CT scan has been performed for screening of intracranial lesiones
Time spent in the ED
Time from admission to discharge. Time from admission to sample obtention. Time from venipuncture to availability of biomarker results.
Compliance with proposed algorithm
Number of patients in whom a CT scan has been performed despinte negative biomarker test
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