Biomarker Levels as A Predictor of Concussion Severity OUTcomes (BlacOut)

The novel aspect of the proposed study relates to the fact that the STNF protein is the first
evidence that a biomarker in human blood can help clinicians determine a specific patient's
clinical outcome from a concussion. This in turn will help clinicians and concussion
specialists with designing treatment protocols very early after the initial injury that could
have significant impacts on the health of the patient.

This study has several important benefits to the scientific community. Concussion treatment
today is uncertain. Some patients are back to baseline one or two days post injury whereas
other patients are experiencing debilitating symptoms for months after the injury. Until the
patient begins to report symptoms, the course of treatment cannot be determined. Other
biomarkers for concussion diagnosis are being evaluated, but this is the first biomarker to
show promise for patient stratification and earlier intervention and treatment for the subset
of cases at high risk of suffering brain damage and persisting dysfunction after concussion.
Currently, no prognostic method exists for identifying at an early and potentially treatable
stage the small subset of concussion sufferers at risk of diffuse axonal injury and
persisting brain functional impairment.

Inclusion Criteria:

Patient is ≥ 8 years old 2. Ability to enroll within 24 hours of injury 3. Ability to
follow-up with patient 30 days following enrollment 4. Concussion by history or physical
examination (head injury and symptoms such as headache, nausea, vomiting, dizziness,
fatigue, irritability, or poor concentration following the injury) 5. GCS ≥ 13 6.
Abbreviated Injury Score (AIS) ≤ 3 7. Plan to be discharged from the emergency department
to the outpatient observation unit or to home

Exclusion Criteria:

Non-English speaking 2. Trauma Team Activation (TTA) 3. Abnormal acute intracranial CT/MRI
findings 4. Blood alcohol level (> 200 mg/dL) 5. Previous head injury within 30 days of
enrollment 6. Pre-existing neurologic disorder associated with cerebral dysfunction and/or
cognitive deficit (such as dementia, cerebral palsy, mental retardation, epilepsy,
dyslexia) 7. Pre-existing psychiatric disorder (such as bipolar disorder and schizophrenia)
as indicated by medical history 8. Planned admission to a hospital inpatient unit