Blood test to help diagnose, predict outcomes, and monitor traumatic brain injury in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Of California Davis, Neurological Surgery
  Sacramento, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Atrium Health - Carolina Medical Center
  Charlotte, North Carolina, United States Recruiting
• University of Cincinnati
  Cincinnati, Ohio, United States Recruiting
• University of Pennsylvania Medical Center
  Philadelphia, Pennsylvania, United States Recruiting
• University of Pittsburgh Medical Center
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Marian Martinez
• Email: marian.martinez@external.roche.com
• Phone: +1-815-394-9084

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.