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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 | Clinical Trials | Clareo Health

RECRUITING

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)

NCT07455136•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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•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
+4 more criteria

Locations (9)

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

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

February 9, 2026

Primary Completion Date

March 31, 2028

Completion Date

May 31, 2028

Last Updated

March 6, 2026

Enrollment

2,000

ESTIMATED participants

Conditions

Traumatic Brain Injury

Interventions

Blood sample collection

PROCEDURE

Contacts

Marian Martinez

CONTACT

+1-815-394-9084 marian.martinez@contractors.roche.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

Hemodynamic ABI Monitor

Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury

Carbon Dioxide Administration and Brain Waste Clearance

Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

Remote Stimulation and Training to Advance Recovery From TBI in Seniors