A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury

Inclusion criteria

• Presenting to the Emergency Department with a biomechanically plausible mechanism of non-penetrating traumatic brain injury (TBI; direct impact: blow to the head, head against object, object against head; acceleration/deceleration)
• Acute brain CT completed for standard of care

Further Inclusion Criteria (specific for CLIN12.2):

• Admitted to the hospital with radiographic evidence of acute TBI
• Admitted to the intensive care unit at risk for decline related to TBI

Exclusion criteria

• Prior neurosurgical intervention within the last 6 months
• Major debilitating neurological disease (such as, but not limited to: stroke, CVA, mild cognitive impairment, Alzheimer's disease, Amyotrophic lateral sclerosis, Parkinson's disease, Huntington's disease, Frontotemporal dementia, tumor, epilepsy, unmanaged seizure disorder), impairing baseline awareness, cognition, or validity of outcomes assessments
• Major debilitating baseline mental health disorders (such as but not limited to schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessments
• Significant pre-existing conditions that would interfere with follow-up and outcome assessment (such as, but not limited to: chronic kidney disease, chronic cardiovascular comorbidities, alcohol or substance use disorder)
• History of melanoma
• Primary diagnosis of ischemic or hemorrhagic stroke
• Any spinal Cord Injury (American Spinal Injury Association [ASIA] score of A-D)
• Received chemotherapy or radiation currently or within the last year
• Patients on psychiatric hold (e.g., 5150, 5250)
• Current incarceration or in custody
• Known inability to undergo an MRI
• Currently receiving any interventional treatments as a part of an investigational study/trial (drug, device, behavioral, treatment) at the time of enrollment and/or during the course of this study
• Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts)
• Any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and/or in their future permanence in the study