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
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
Admitted to the hospital with radiographic evidence of acute TBI
Admitted to the intensive care unit at risk for decline related to TBI
You may not be if
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
Clareo Health | 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
