For people ages 18 years and up
Acute Blood Biomarker Branch Subject Inclusion Criteria:
- 18 years of age or older.
- Subject or Legally Authorized Representative (LAR) provided informed consent for the Acute Blood Biomarker Branch (waiver of consent may be acceptable, per IRB).
- Subject presented to a health care facility or emergency department with a suspected TBI resulting from an insult to the head by an external force within 12 hours of the injury.
- Subject has a 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.
- 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.
- Any period of loss of consciousness
- Any loss of memory for events immediately before or after the injury
- Any alteration of mental state at the time of the injury
- Focal neurological deficits that may or may not be transient
Acute Blood Biomarker Branch Subject Exclusion Criteria.
- Previous enrollment in this study
- Current (on-going) enrollment in a therapeutic or interventional clinical trial (drug or device)
- Primary diagnosis at the enrolling facility of ischemic or hemorrhagic stroke
- Time of injury is unknown and cannot be estimated
- Presented with penetrating head trauma or spinal cord injury (American Spinal Injury Association [ASIA] score of C or worse) at the enrolling facility
- Standard of care head CT scan procedures not completed prior to Emergency Department (ED) discharge
- Prisoners or patients in custody
- Patients on psychiatric hold
Follow-up Branch Subject Inclusion Criteria.
- Enrollment in Acute Blood Biomarker Branch
- Subject or LAR provided informed consent for the Acute Blood Biomarker Branch and the Follow-up Branch
Follow up Branch Subject Exclusion Criteria.
- Conditions or circumstances that would interfere with follow-up and outcome assessment, as determined by the principal investigator or delegate. Examples include.
- Significant polytrauma
- Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder)
- Major debilitating neurological disease (e.g. stroke, cerebrovascular accident, dementia, tumor)