The study is intended to cover two purposes: first, to develop a blood-based biomarker test for aiding the diagnosis of traumatic brain injury (TBI) in adult participants and for prognosis of outcome of TBI (CLIN12.1); and second, for monitoring the development of secondary events in adult participants diagnosed with TBI (CLIN12.2).
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
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)
Hoffmann-La Roche
Lead sponsor
Roche Diagnostics GmbH
Collaborator