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RECRUITING
NCT07455136

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

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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