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NCT07455136Recruiting

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

Hoffmann-La Roche

Start Date

2/9/2026

Completion Date

11/23/2028

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Presenting to the Emergency Department with a biomechanically plausible mechanism of non-penetrating traumatic brain injury (TBI; direct impact: blow to the head, head against object, object against head; acceleration/deceleration) * Acute brain CT completed for standard of care Further Inclusion Criteria (specific for CLIN12.2): * Admitted to the hospital with radiographic evidence of acute TBI * Admitted to the intensive care unit at risk for decline related to TBI Exclusion Criteria: * Prior neurosurgical intervention within the last 6 months * Major debilitating neurological disease (such as, but not limited to: stroke, CVA, mild cognitive impairment, Alzheimer's disease, Amyotrophic lateral sclerosis, Parkinson's disease, Huntington's disease, Frontotemporal dementia, tumor, epilepsy, unmanaged seizure disorder), impairing baseline awareness, cognition, or validity of outcomes assessments * Major debilitating baseline mental health disorders (such as but not limited to schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessments * Significant pre-existing conditions that would interfere with follow-up and outcome assessment (such as, but not limited to: chronic kidney disease, chronic cardiovascular comorbidities, alcohol or substance use disorder) * History of melanoma * Primary diagnosis of ischemic or hemorrhagic stroke * Any spinal Cord Injury (American Spinal Injury Association \[ASIA\] score of A-D) * Received chemotherapy or radiation currently or within the last year * Patients on psychiatric hold (e.g., 5150, 5250) * Current incarceration or in custody * Known inability to undergo an MRI * Currently receiving any interventional treatments as a part of an investigational study/trial (drug, device, behavioral, treatment) at the time of enrollment and/or during the course of this study * Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts) * Any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and/or in their future permanence in the study

Interventions

PROCEDURE

Blood sample collection

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Conditions

Traumatic Brain Injury

Locations

University Of California Davis, Neurological Surgery

Sacramento, California 95817

United States

University of California San Francisco

San Francisco, California 94110

United States

Goodman Campbell Brain and Spine/Ascension

Carmel, Indiana 46032

United States

Northwell Health - Department Of Neurosurgery

Manhasset, New York 11030

United States

Atrium Health - Carolina Medical Center

Charlotte, North Carolina 28203

United States

University of Cincinnati

Cincinnati, Ohio 45229

United States

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania 19104

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States

Brown University

Providence, Rhode Island 29903

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37203

United States

University of Utah

Salt Lake City, Utah 84132

United States

University of Wisconsin

Madison, Wisconsin 53792

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States