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
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)
1 other identifier
observational
2,000
1 country
12
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2026
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2026
CompletedFirst Submitted
Initial submission to the registry
March 3, 2026
CompletedFirst Posted
Study publicly available on registry
March 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
April 30, 2026
April 1, 2026
2.1 years
March 3, 2026
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (12)
Percentage of Participants According to Traumatic Brain Injury (TBI) Diagnosis (Positive or Negative), Assessed by an Adjudication Panel Based on Structural Imaging (CT and MRI) and Clinical Summaries
Up to 2 weeks post-injury
Glasgow Outcome Scale-Extended (GOSE)-TBI Scores at Specified Timepoints
Days 14, 28, and 90
Percentage of Participants According to Neuroworsening Result (Positive or Negative), Assessed by an Adjudication Panel Based on Clinical and Radiological Findings
Up to 2 weeks post-injury
Percentage of Hospitalized Participants with Secondary Events, Based on CT Scan Findings per the Standard of Care
Up to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with TBI Diagnosis
From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of First Panel of Biomarkers Compared with TBI Diagnosis
From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with Neuroworsening Results
From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of First Panel of Biomarkers Compared with Neuroworsening Results
From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with GOSE-TBI Scores
Days 14, 28, and 90
CLIN12.1: Specificity of First Panel of Biomarkers Compared with GOSE-TBI Scores
Days 14, 28, and 90
CLIN12.2: Sensitivity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Up to 2 weeks post-injury
CLIN12.2: Specificity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Up to 2 weeks post-injury
Secondary Outcomes (8)
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with TBI Diagnosis
From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with TBI Diagnosis
From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with Neuroworsening Results
From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with Neuroworsening Results
From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with GOSE-TBI Scores
Days 14, 28, and 90
- +3 more secondary outcomes
Study Arms (2)
Cohort 1: Participants with Suspected TBI
Cohort 2: Hospitalized Participants with TBI
Interventions
Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.
Eligibility Criteria
Participants who present at the emergency department with suspected TBI as per the eligibility criteria from approximately 10 to 15 sites in geographically diverse locations within the United States.
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
- Admitted to the hospital with radiographic evidence of acute TBI
- Admitted to the intensive care unit at risk for decline related to TBI
You may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Roche Diagnostics GmbHcollaborator
Study Sites (12)
University Of California Davis, Neurological Surgery
Sacramento, California, 95817, United States
University of California San Francisco
San Francisco, California, 94110, United States
Goodman Campbell Brain and Spine/Ascension
Carmel, Indiana, 46032, United States
Atrium Health - Carolina Medical Center
Charlotte, North Carolina, 28203, United States
University of Cincinnati
Cincinnati, Ohio, 45229, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Brown University
Providence, Rhode Island, 29903, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Biospecimen
Blood serum and plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Roche Diagnostics GmbH
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2026
First Posted
March 6, 2026
Study Start
February 9, 2026
Primary Completion (Estimated)
March 31, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share