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).
Study Type
OBSERVATIONAL
Enrollment
2,000
Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.
University Of California Davis, Neurological Surgery
Sacramento, California, United States
NOT_YET_RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGGoodman Campbell Brain and Spine/Ascension
Carmel, Indiana, United States
NOT_YET_RECRUITINGAtrium Health - Carolina Medical Center
Charlotte, North Carolina, United States
NOT_YET_RECRUITINGUniversity of Cincinnati
Cincinnati, Ohio, United States
NOT_YET_RECRUITINGUniversity of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
NOT_YET_RECRUITINGUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
NOT_YET_RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
NOT_YET_RECRUITINGUniversity of Utah
Salt Lake City, Utah, United States
NOT_YET_RECRUITINGUniversity of Wisconsin
Madison, Wisconsin, United States
NOT_YET_RECRUITING...and 1 more locations
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
Time frame: Up to 2 weeks post-injury
Glasgow Outcome Scale-Extended (GOSE)-TBI Scores at Specified Timepoints
Time frame: 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
Time frame: Up to 2 weeks post-injury
Percentage of Hospitalized Participants with Secondary Events, Based on CT Scan Findings per the Standard of Care
Time frame: Up to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with TBI Diagnosis
Time frame: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of First Panel of Biomarkers Compared with TBI Diagnosis
Time frame: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with Neuroworsening Results
Time frame: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of First Panel of Biomarkers Compared with Neuroworsening Results
Time frame: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with GOSE-TBI Scores
Time frame: Days 14, 28, and 90
CLIN12.1: Specificity of First Panel of Biomarkers Compared with GOSE-TBI Scores
Time frame: Days 14, 28, and 90
CLIN12.2: Sensitivity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Time frame: Up to 2 weeks post-injury
CLIN12.2: Specificity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Time frame: Up to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with TBI Diagnosis
Time frame: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with TBI Diagnosis
Time frame: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with Neuroworsening Results
Time frame: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with Neuroworsening Results
Time frame: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with GOSE-TBI Scores
Time frame: Days 14, 28, and 90
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with GOSE-TBI Scores
Time frame: Days 14, 28, and 90
CLIN12.2: Sensitivity of a Second Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Time frame: Up to 2 weeks post-injury
CLIN12.2: Specificity of a Second Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Time frame: Up to 2 weeks post-injury
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