What this study is
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).
What's being tested
- Blood sample collection
Intervention · PROCEDURE
Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.
Study details
- Official title
- 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)
- Sponsor
- Hoffmann-La Roche
- Conditions
- Traumatic Brain Injury
- Enrolling
- 2,000 people
- Starts
- 2026-02-09
- Est. completion
- 2028-11-23
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedAll participants
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 (specific for CLIN12.2)
You may qualify if
- Admitted to the hospital with radiographic evidence of acute TBI
- Admitted to the intensive care unit at risk for decline related to TBI
You can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (14)
13 openUniversity Of California Davis, Neurological Surgery
Sacramento, California, United States
RecruitingUniversity of California San Francisco
San Francisco, California, United States
RecruitingGoodman Campbell Brain and Spine/Ascension
Carmel, Indiana, United States
Not yet recruitingNorthwell Health - Department Of Neurosurgery
Manhasset, New York, United States
Not yet recruitingAtrium Health - Carolina Medical Center
Charlotte, North Carolina, United States
RecruitingUniversity of Cincinnati
Cincinnati, Ohio, United States
RecruitingUniversity of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
RecruitingUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
RecruitingBrown University
Providence, Rhode Island, United States
Not yet recruitingVanderbilt University Medical Center
Nashville, Tennessee, United States
Not yet recruitingBaylor College of Medicine
Houston, Texas, United States
Not yet recruitingUniversity of Utah
Salt Lake City, Utah, United States
Not yet recruitingMedical College of Wisconsin
Milwaukee, Wisconsin, United States
Not yet recruitingUniversity of Wisconsin
Madison, Wisconsin, United States
Withdrawn
Study team
Sponsor
Hoffmann-La Roche
Study ID RD007282
Study director
Clinical Trials
Roche Diagnostics GmbH
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.