Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma

Head Injured Cohorts Inclusion Criteria:

- At least 18 years of age at screening.

- Presented with a suspected traumatically induced head injury, as a result of insult
to the head from an external force.

- Workup includes head CT scan, as part of clinical emergency care and CT result
(CT-positive or CT-negative for acute intracranial lesions) based on the local
neuroradiologist's review is available to study staff.

- CT scan and CT report used to determine eligibility must be available.

- Glasgow Coma Scale score of 13-15 at the time of Informed Consent.

- Weighs at least 110lbs (50kg), has not donated blood within the last 8 weeks, and is
not anemic or has any other blood disorder which requires routine transfusions.

- First study blood sample is able to be collected into a cohort that has not been
closed to enrollment

- Able to participate for up to 11 days following head injury.

- Subject or legal representative is willing to undergo the Informed Consent process
prior to enrollment into this study.

- FOR CT NEGATIVE COHORTS ONLY: Subject must have experienced a Loss of Consciousness
(LOC) < 30 minutes, any Alteration of Consciousness (AOC), or any Post-traumatic
amnesia (PTA) following the suspected head injury AND be expected to be admitted to
the hospital, or remain in hospital for at least 24 hours in order to complete Visit
1 blood draws

Head Injured Cohorts Exclusion Criteria:

- Participating in an interventional, therapeutic clinical study that may affect the
results of this study (an observational study would be acceptable).

- Time of injury cannot be determined.

- Primary diagnosis of ischemic or hemorrhagic stroke.

- Venipuncture not feasible

- Neurodegenerative disease or other neurological disorder including dementia,
Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.

- History of neurosurgery within the last 30 days.

- Administration of blood transfusion after head injury and prior to the study blood
draw.

- Female who is pregnant or lactating.

- Subject is otherwise determined by the Investigator to be an unsuitable candidate for
participation.

Control Cohort Inclusion Criteria

- At least 18 years of age at screening

- Weighs at least 110lbs (50kg), has not donated blood within the last 8 weeks, and is
not anemic or has any other blood disorder which requires routine transfusions.

- Healthy with no chronic or acute medical, neurologic, or psychiatric conditions (to
the best of their knowledge).

- Able to participate for up to 5 hours following the first study blood draw.

- Willing to undergo the Informed Consent process prior to enrollment into this study.

- Subject is able to be enrolled into a control cohort that has not yet been closed to
enrollment

Control Cohort Exclusion Criteria

- Participating in an interventional, therapeutic clinical study that may affect
results of this study (an observational study would be acceptable).

- Subject has sustained any significant bodily injury within the past week.

- Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture
sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis)
both upper limbs missing (congenital or amputee)).

- Neurodegenerative disease or other neurological disorder including dementia,
Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.

- Female who is pregnant or lactating

- History of neurosurgery within the last 30 days.

- Subject is otherwise determined by the Investigator to be an unsuitable candidate for
participation