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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
Sponsor: Hoffmann-La Roche
Summary
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).
Official title: A Multicenter Prospective Study to Develop a Blood-based Biomarker Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adult Subjects (CLIN12.1) and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury (CLIN12.2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2026-02-09
Completion Date
2028-05-31
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Blood sample collection
Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.
Locations (11)
University Of California Davis, Neurological Surgery
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Goodman Campbell Brain and Spine/Ascension
Carmel, Indiana, United States
Atrium Health - Carolina Medical Center
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States
University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States