Actively 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
Led by Hoffmann-La Roche · Updated on 2026-04-30
2000
Participants Needed
12
Research Sites
120 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
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).
CONDITIONS
Official 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 plausible non-penetrating traumatic brain injury mechanism
- Completed an acute brain CT scan as part of standard care
- For monitoring secondary events: admitted to hospital with radiographic evidence of acute TBI
- For monitoring secondary events: admitted to intensive care unit at risk for TBI-related decline
You will not qualify if you...
- Neurosurgical intervention within the last 6 months
- Major debilitating neurological diseases impairing baseline cognition or assessment validity
- Major debilitating mental health disorders interfering with follow-up
- Significant pre-existing conditions affecting follow-up or outcome assessment
- History of melanoma
- Primary diagnosis of ischemic or hemorrhagic stroke
- Any spinal cord injury with ASIA score A-D
- Current or recent (within 1 year) chemotherapy or radiation
- Psychiatric hold status
- Current incarceration or custody
- Known inability to undergo MRI
- Participation in other interventional clinical studies
- Low likelihood of follow-up or unreliable contact information
- Any condition that may interfere with study procedures or participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 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
Atrium Health - Carolina Medical Center
Charlotte, North Carolina, United States, 28203
Not Yet Recruiting
5
University of Cincinnati
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
6
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
7
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
8
Brown University
Providence, Rhode Island, United States, 29903
Not Yet Recruiting
9
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
10
University of Utah
Salt Lake City, Utah, United States, 84132
Not Yet Recruiting
11
University of Wisconsin
Madison, Wisconsin, United States, 53792
Withdrawn
12
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
Research Team
M
Marian Martinez
CONTACT
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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