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

Recruiting now

Conditions studied: Traumatic Brain Injury

In brief

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).

Key facts

Study ID

NCT07455136

Run by

Hoffmann-La Roche

People needed

2000

Starts

2026-02-09

Expected to finish

2028-11-23

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California San Francisco — San Francisco, California, United States (enrolling)
• Atrium Health - Carolina Medical Center — Charlotte, North Carolina, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States
• University of Wisconsin — Madison, Wisconsin, United States
• University Of California Davis, Neurological Surgery — Sacramento, California, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Goodman Campbell Brain and Spine/Ascension — Carmel, Indiana, United States
• Northwell Health - Department Of Neurosurgery — Manhasset, New York, United States
• Brown University — Providence, Rhode Island, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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