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).
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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
Timeframe: Up to 2 weeks post-injury
Glasgow Outcome Scale-Extended (GOSE)-TBI Scores at Specified Timepoints
Timeframe: Days 14, 28, and 90
Percentage of Participants According to Neuroworsening Result (Positive or Negative), Assessed by an Adjudication Panel Based on Clinical and Radiological Findings
Timeframe: Up to 2 weeks post-injury
Percentage of Hospitalized Participants with Secondary Events, Based on CT Scan Findings per the Standard of Care
Timeframe: Up to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with TBI Diagnosis
Timeframe: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of First Panel of Biomarkers Compared with TBI Diagnosis
Timeframe: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with Neuroworsening Results
Timeframe: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of First Panel of Biomarkers Compared with Neuroworsening Results
Timeframe: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with GOSE-TBI Scores
Timeframe: Days 14, 28, and 90
CLIN12.1: Specificity of First Panel of Biomarkers Compared with GOSE-TBI Scores
Timeframe: Days 14, 28, and 90
CLIN12.2: Sensitivity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Timeframe: Up to 2 weeks post-injury
CLIN12.2: Specificity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Timeframe: Up to 2 weeks post-injury