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)
Participants who present at the emergency department with suspected TBI as per the eligibility criteria from approximately 10 to 15 sites in geographically diverse locations within the United States.
Cohort
Prospective
Blood sample collection
Procedure/SurgeryBlood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.
Percentage of Participants According to Traumatic Brain Injury (TBI) Diagnosis (Positive or Negative), Assessed by an Adjudication Panel Based on Structural Imaging (CT and MRI) and Clinical Summaries
Glasgow Outcome Scale-Extended (GOSE)-TBI Scores at Specified Timepoints
Percentage of Participants According to Neuroworsening Result (Positive or Negative), Assessed by an Adjudication Panel Based on Clinical and Radiological Findings
Percentage of Hospitalized Participants with Secondary Events, Based on CT Scan Findings per the Standard of Care
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with TBI Diagnosis
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with TBI Diagnosis
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with Neuroworsening Results
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with Neuroworsening Results
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Hoffmann-La Roche
Lead sponsor
Roche Diagnostics GmbH
Collaborator
