RecruitingNCT07455136

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

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)

Sponsor

Hoffmann-La Roche

Enrollment

2,000 participants

Start Date

Feb 9, 2026

Study Type

OBSERVATIONAL

Conditions

Traumatic Brain Injury

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Blood sample collection for people with traumatic brain injury. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBlood sample collection

Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.

Locations(13)

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

Northwell Health - Department Of Neurosurgery

Manhasset, New York, 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

Brown University

Providence, Rhode Island, 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

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