Blood test to help diagnose, predict outcomes, and monitor traumatic brain injury in adults
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)
This project will try a blood test to help diagnose and predict outcomes for adults with non-penetrating traumatic brain injury and to monitor for secondary problems while they are hospitalized.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 12 sites (Sacramento, California and 11 other locations) |
| Trial ID | NCT07455136 on ClinicalTrials.gov |
What this trial studies
This is an observational program led by Hoffmann‑La Roche with academic sites that collects blood samples to develop a biomarker test for both diagnosing and prognosing adult traumatic brain injury and for monitoring in-hospital secondary events. It enrolls adults who present to the emergency department after a biomechanically plausible non‑penetrating head injury and who have acute brain CT as part of routine care, plus a subgroup admitted with radiographic TBI or in the ICU at risk for decline. Researchers will correlate blood biomarker levels with CT findings, clinical course, and outcomes to identify patterns that predict injury severity, recovery, or new complications. Key exclusions include recent neurosurgery and major preexisting neurological or severe psychiatric conditions that would confound results.
Who should consider this trial
Good fit: Adults with a non‑penetrating head injury who undergo a standard acute brain CT in the emergency department, and adults admitted to hospital or ICU with radiographic evidence of TBI for in-hospital monitoring, are the intended participants.
Not a fit: Patients with recent neurosurgery, major debilitating neurodegenerative or unmanaged severe psychiatric disorders, penetrating head injuries, or those who do not receive an acute CT are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the blood test could allow faster, less invasive diagnosis, help predict recovery, and give earlier warning of worsening brain injury during hospitalization.
How similar studies have performed: Prior studies using blood biomarkers such as GFAP and UCH‑L1 have supported blood-based detection and CT rule-out for brain injury, but using blood tests to monitor in-hospital secondary events is less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sacramento, California and 11 other locations
- University Of California Davis, Neurological Surgery — Sacramento, California, United States (Not_yet_recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Goodman Campbell Brain and Spine/Ascension — Carmel, Indiana, United States (Not_yet_recruiting)
- Atrium Health - Carolina Medical Center — Charlotte, North Carolina, United States (Not_yet_recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Not_yet_recruiting)
- University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
- Brown University — Providence, Rhode Island, United States (Not_yet_recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Not_yet_recruiting)
- University of Utah — Salt Lake City, Utah, United States (Not_yet_recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Withdrawn)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Marian Martinez
- Email: marian.martinez@external.roche.com
- Phone: +1-815-394-9084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.