Actively Recruiting
A Multicenter Prospective Study to Develop a Blood-based Biomarker Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adult Subjects and for Monitoring Secondary Events in Patients with Traumatic Brain Injury
Led by Hoffmann-La Roche · Updated on 2026-06-01
2000
Participants Needed
13
Research Sites
8 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
R
Roche Diagnostics GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring ways to develop a blood test that can help diagnose traumatic brain injury (TBI) in adults and predict outcomes. The study also aims to monitor secondary issues that can arise after a TBI. This research involves adult participants who have experienced a non-penetrating TBI and is sponsored by Hoffmann-La Roche. Participants are divided into two groups: those suspected of having TBI and those hospitalized with confirmed TBI. Blood samples will be collected from all participants to study biomarkers related to diagnosis, prognosis, and secondary event development. The study observes participants up to 90 days after injury, using standard clinical imaging and assessments. During the study, participants will undergo blood draws and clinical evaluations including CT and MRI scans, along with outcome assessments such as the Glasgow Outcome Scale-Extended (GOSE). Researchers will track biomarker sensitivity and specificity for diagnosis and monitoring over time, especially within the first two weeks post-injury. The study runs until May 2028, with participants monitored at several points to evaluate their recovery and secondary complications.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presenting to the Emergency Department with a non-penetrating traumatic brain injury caused by a plausible mechanism
- Undergoing acute brain CT scan as part of standard care
- For hospitalized participants: admitted with radiographic evidence of acute TBI
- For hospitalized participants: admitted to intensive care unit at risk for decline related to TBI
- Age 18 years or older
You will not qualify if you...
- Neurosurgical intervention within the last 6 months
- Major neurological diseases affecting awareness or cognition (e.g., stroke, Alzheimer's, Parkinson's, epilepsy)
- Major baseline mental health disorders interfering with follow-up (e.g., schizophrenia, bipolar disorder)
- Significant pre-existing conditions interfering with follow-up (e.g., chronic kidney disease, cardiovascular disease, substance use disorder)
- History of melanoma
- Primary diagnosis of ischemic or hemorrhagic stroke
- Any spinal cord injury (ASIA score A-D)
- Receiving chemotherapy or radiation currently or within last year
- On psychiatric hold
- Current incarceration or custody
- Unable to undergo MRI
- Enrolled in another interventional clinical trial
- Low likelihood of follow-up (e.g., unstable residence, lack of reliable contacts)
- Any condition judged by investigator to interfere with study participation or retention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks post-injury
Participants undergo blood sample collection and brain imaging as part of standard care to aid diagnosis and prognosis of traumatic brain injury.
Multiple visits up to 2 weeks post-injury
Duration - Up to 90 days post-injury
Participants are monitored with follow-up assessments to evaluate recovery and development of secondary events after traumatic brain injury.
Follow-up assessments on Days 14, 28, and 90
Trial Site Locations
Total: 13 locations
1
University Of California Davis, Neurological Surgery
Sacramento, California, United States, 95817
Not Yet Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
3
Goodman Campbell Brain and Spine/Ascension
Carmel, Indiana, United States, 46032
Not Yet Recruiting
4
Northwell Health - Department Of Neurosurgery
Manhasset, New York, United States, 11030
Not Yet Recruiting
5
Atrium Health - Carolina Medical Center
Charlotte, North Carolina, United States, 28203
Actively Recruiting
6
University of Cincinnati
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
7
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
8
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
9
Brown University
Providence, Rhode Island, United States, 29903
Not Yet Recruiting
10
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
11
University of Utah
Salt Lake City, Utah, United States, 84132
Not Yet Recruiting
12
University of Wisconsin
Madison, Wisconsin, United States, 53792
Withdrawn
13
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
Research Team
M
Marian Martinez
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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