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

May 29, 2026 updated by: Hoffmann-La Roche

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Not yet recruiting
        • University Of California Davis, Neurological Surgery
      • San Francisco, California, United States, 94110
        • Recruiting
        • University of California San Francisco
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Not yet recruiting
        • Goodman Campbell Brain and Spine/Ascension
    • New York
      • Manhasset, New York, United States, 11030
        • Not yet recruiting
        • Northwell Health - Department Of Neurosurgery
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Atrium Health - Carolina Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Not yet recruiting
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • University of Pennsylvania Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 29903
        • Not yet recruiting
        • Brown University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Vanderbilt University Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Not yet recruiting
        • University of Utah
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Withdrawn
        • University of Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1: Participants with Suspected TBI
Procedure: Blood sample collection
Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.
Cohort 2: Hospitalized Participants with TBI
Procedure: Blood sample collection
Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: Up to 2 weeks post-injury
Up to 2 weeks post-injury
Glasgow Outcome Scale-Extended (GOSE)-TBI Scores at Specified Timepoints
Time Frame: Days 14, 28, and 90
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
Time Frame: Up to 2 weeks post-injury
Up to 2 weeks post-injury
Percentage of Hospitalized Participants with Secondary Events, Based on CT Scan Findings per the Standard of Care
Time Frame: Up to 2 weeks post-injury
Up to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with TBI Diagnosis
Time Frame: From Day 1 to 2 weeks post-injury
From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of First Panel of Biomarkers Compared with TBI Diagnosis
Time Frame: From Day 1 to 2 weeks post-injury
From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with Neuroworsening Results
Time Frame: From Day 1 to 2 weeks post-injury
From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of First Panel of Biomarkers Compared with Neuroworsening Results
Time Frame: From Day 1 to 2 weeks post-injury
From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with GOSE-TBI Scores
Time Frame: Days 14, 28, and 90
Days 14, 28, and 90
CLIN12.1: Specificity of First Panel of Biomarkers Compared with GOSE-TBI Scores
Time Frame: Days 14, 28, and 90
Days 14, 28, and 90
CLIN12.2: Sensitivity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Time Frame: Up to 2 weeks post-injury
Up to 2 weeks post-injury
CLIN12.2: Specificity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Time Frame: Up to 2 weeks post-injury
Up to 2 weeks post-injury

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with TBI Diagnosis
Time Frame: From Day 1 to 2 weeks post-injury
From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with TBI Diagnosis
Time Frame: From Day 1 to 2 weeks post-injury
From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with Neuroworsening Results
Time Frame: From Day 1 to 2 weeks post-injury
From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with Neuroworsening Results
Time Frame: From Day 1 to 2 weeks post-injury
From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with GOSE-TBI Scores
Time Frame: Days 14, 28, and 90
Days 14, 28, and 90
CLIN12.1: Specificity of Second Panel of Biomarkers Compared with GOSE-TBI Scores
Time Frame: Days 14, 28, and 90
Days 14, 28, and 90
CLIN12.2: Sensitivity of a Second Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Time Frame: Up to 2 weeks post-injury
Up to 2 weeks post-injury
CLIN12.2: Specificity of a Second Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
Time Frame: Up to 2 weeks post-injury
Up to 2 weeks post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Diagnostics GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Roche Diagnostics Gmbh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RD007282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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