Clinical Evaluation of the i-STAT TBI Test

For people ages 18 years and up

Acute Blood Biomarker Branch Subject Inclusion Criteria:

1. 18 years of age or older.
2. Subject or Legally Authorized Representative (LAR) provided informed consent for the Acute Blood Biomarker Branch (waiver of consent may be acceptable, per IRB).
3. Subject presented to a health care facility or emergency department with a suspected traumatic brain injury resulting from an insult to the head by an external force within 12 hours of the injury.
4. Subject has a computed tomography (CT) scan of the head with all sequences (bone and soft tissue) ordered as part of standard of care at the enrolling facility, or are transferred to the enrolling facility with a head CT scan sent from the originating facility.
5. As a result of this head injury, the subject has sustained a traumatically induced physiological disruption of brain function, as manifested by at least one of the following:
   1. Any period of loss of consciousness
   2. Any loss of memory for events immediately before or after the injury
   3. Any alteration of mental state at the time of the injury
   4. Focal neurological deficits that may or may not be transient

Acute Blood Biomarker Branch Subject Exclusion Criteria:

1. Previous enrollment in this study, CS-2018-0009
2. Current (on-going) enrollment in a therapeutic or interventional clinical trial (drug or device)
3. Primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke
4. Time of injury is unknown and cannot be estimated
5. Presented with penetrating head trauma or spinal cord injury (American Spinal Injury Association [ASIA] score of C or worse) at the enrolling facility
6. Standard of care head CT scan procedures not completed prior to Emergency Department (ED) discharge.
7. Prisoners or patients in custody
8. Patients on psychiatric hold

Follow-up Branch Subject Inclusion Criteria:

1. Enrollment in Acute Blood Biomarker Branch
2. Subject or LAR provided informed consent for the Acute Blood Biomarker Branch and the Follow-up Branch

Follow up Branch Subject Exclusion Criteria:

1. Conditions or circumstances that would interfere with follow-up and outcome assessment, as determined by the principal investigator or delegate. Examples include:
2. Significant polytrauma
3. Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder)
4. Major debilitating neurological disease (e.g. stroke, cerebrovascular accident, dementia, tumor)