Mild Traumatic Brain InjuryNCT06449183
VIDAS® TBI Real Life Performance in Subjects With Mild Traumatic Brain Injury (mTBI)
A study testing VIDAS® TBI Test [GFAP and UCH-L1 assays] in people with Mild Traumatic Brain Injury, run by BioMérieux at 5 sites in United States.
Trial summary
Decision Rules for an initial CT-scan in patients arriving to Emergency Department (ED) and presenting a mild traumatic brain injury could be optimized by the use of an objective parameter easily and rapidly measured. This may be the place for serum biomarkers providing a quick and accurate assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- VIDAS® TBI Test [GFAP and UCH-L1 assays]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 903 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 May 2024to 12 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subject ≥ 18 years old
- Subject with a Glasgow Coma Scale (GCS) score between 13-15 on admission
- Subject presenting to the Emergency Department for suspected mild Traumatic Brain Injury
- Subject with a non-contrast head Computed Tomography (CT) scan ordered per the clinical site's care usual care
- Blood sampling possible within 12 hours of injury (1 tube of 4-5 mL of blood)
- Subject expected to stay at least 2 hours in the ED or in a ward
- Subject with signed Informed Consent Form (ICF)
Who cannot join
- Time of injury unknown
- Subject with non-traumatic neurological disorders (e.g, dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, spontaneous intracranial haematoma)
- Neurosurgery, stroke or transient ischemic attack within the last 30 days
- Subject with an active cancer
- Subject with penetrating head injury
- Special populations, including women with known pregnancy, prisoners, or institutionalized individuals
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Wayne State University
Detroit, Michigan, 48202
Orlando Health
Orlando, Florida, 32806
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14627
Washington University
St Louis, Missouri, 63130
About this study
Official title: Real-life Performance and Added Value of the VIDAS® TBI Blood Test in the Assessment of Mild Traumatic Brain Injury (mTBI), in Subjects With a Glasgow Coma Scale (GCS) Between 13-15
Decision Rules for an initial CT-scan in patients arriving to Emergency Department (ED) and presenting a mild traumatic brain injury could be optimized by the use of an objective parameter easily and rapidly measured. This may be the place for serum biomarkers providing a quick and accurate assessment. BioMérieux has now developed an automated assay for the measurement of serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1), the VIDAS® TBI assay to fill out this unmet needs. The goal of the herein study is to generate real-world data and evidences to support the VIDAS® TBI performances.
Read the detailed description
The assessment of severity of TBI patients is based on the Glasgow Coma Scale (GCS) and the initial management in the ED includes performing a non-contrast brain Computed Tomography (CT) scan if the patient meets specific conditions. To date, real world data show that EDs would actually not follow guideline recommendations and a substantial CT overuse is observed. Management strategies are becoming more and more focused on selective CT use to effectively manage health care resources. Efforts have been made to optimize the indications for brain CT scan after mTBI. Although brain CT scan plays a central role after mTBI, there is an unmet clinical need for an objective tool to optimize indications for CT scan, reduce patient radiation exposure, and possibly predict patient outcome. Clinical Decision Rules for an initial CT-scan could be optimized by the use of an objective parameter easily and rapidly measured. This may be the place for serum biomarkers providing a quick and accurate assessment. BioMérieux has now developed an automated assay for the measurement of serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1), the VIDAS® TBI assay to fill out this unmet needs. The goal of the herein study is to generate real-world data and evidences to support the VIDAS® TBI performances.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- VIDAS® TBI Test [GFAP and UCH-L1 assays]
- Keywords
- Mild Traumatic Brain Injury, mTBI, TBI, Biomarkers, Automated assays, Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1), Glial Fibrillary Acidic Protein (GFAP), Canadian CT Head Rule, Canadian CT Head Rule (CCHR), Performance, Economic outcomes, Clinical outcomes, CT-Scan, Emergency Department (ED)
- Medical subject headings
- Brain Concussion, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIDAS® TBI Test [GFAP and UCH-L1 assays]Diagnostic test
The VIDAS® TBI (GFAP, UCH-L1) test is composed of two automated assays - VIDAS® TBI (GFAP) and VIDAS® TBI (UCH-L1) - to be used on the VIDAS® family of instruments for the quantitative measurement of Glial 15 Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase- L1 (UCH-L1) in human serum using the Enzyme Linked Fluorescent Assay (ELFA) technique. The results of both assays are required to obtain an overall qualitative test interpretation.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Mild Traumatic Brain injury | Experimental | Subjects presenting to the ED within 12 hours of suspected mild head trauma and a Glasgow Score of 13-15 undergo to blood collection for VIDAS® TBI [GFAP, UCH-L1] testing. Receives: Diagnostic Test: VIDAS® TBI Test [GFAP and UCH-L1 assays] |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine VIDAS® TBI sensitivity to exclude the presence of an intracranial lesion
Measured: 12 hours post mild brain trauma
To determine VIDAS® TBI specificity to exclude the presence of an intracranial lesion
Measured: 12 hours post mild brain trauma
To determine VIDAS® TBI Positive Predictive Value to exclude the presence of an intracranial lesion
Measured: 12 hours post mild brain trauma
To determine VIDAS® TBI Negative Predictive Value to exclude the presence of an intracranial lesion
Measured: 12 hours post mild brain trauma
To determine VIDAS® TBI Positive Likelihood Ratio to exclude the presence of an intracranial lesion
Measured: 12 hours post mild brain trauma
To assess VIDAS® TBI Negative Likelihood Ratio to exclude the presence of an intracranial lesion
Measured: 12 hours post mild brain trauma
Secondary outcomes (15)
To determine Canadian CT Head Rule specificity combined to VIDAS specificity to exclude the presence of an intracranial lesion
Measured: 12 hours post mild brain trauma
To determine Canadian CT Head Rule sensitivity combined to VIDAS sensitivity to exclude the presence of an intracranial lesion
Measured: 12 hours post mild brain trauma
To determine Canadian CT Head Rule Positive Predictive Value combined to VIDAS positive Predictive Value to exclude the presence of an intracranial lesion
Measured: 12 hours post mild brain trauma
To determine Canadian CT Head Rule Negative Predictive Value combined to VIDAS Negative Predictive Value to exclude the presence of an intracranial lesion
Measured: 12 hours post mild brain trauma
To determine Canadian CT Head Rule Negative Likelihood Ratio combined to VIDAS Negative Likelihood Ration to exclude the presence of an intracranial lesion
Measured: 12 hours post mild brain trauma
To determine Canadian CT Head Rule Positive Likelihood Ratio combined to VIDAS Positive Likelihood Ration to exclude the presence of an intracranial lesion
Measured: 12 hours post mild brain trauma
To estimate the impact of the use of VIDAS® TBI on the time to discharge
Measured: 3 months
To estimate the expected impact of the use of VIDAS® TBI on patient stay in the ED
Measured: 3 months
To estimate the expected impact of the use of VIDAS® TBI on hospitalization decision
Measured: 3 months
To estimate the expected impact of the use of VIDAS® TBI on time to medical decision
Measured: 3 months
To estimate the impact of the use of VIDAS® TBI on the patient's monitoring duration
Measured: 3 months
to measure the percentage of CT-scan potentially avoided
Measured: 3 months
To estimate the saving costs when using VIDAS® TBI in comparison with usual clinical sites' care.
Measured: 3 months
To estimate the costs of Length of stay in Emergency Department (ED) when using VIDAS® TBI in comparison with usual clinical sites' care.
Measured: 3 months
To estimate the associated costs of Length of stay in the hospital when using VIDAS® TBI in comparison with usual clinical sites' care.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start16 May 2024
- Primary completion3 Sep 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Prospective Cohort. Multicentric, International clinical study.
- Masking
- None (open label)
- Enrolment
- 903 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449183
- Sponsor's protocol ID
- BM-2023-12
- Status last verified
- Sep 2025
- First submitted
- 3 Jun 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Performance and Added Value of the VIDAS® TBI Blood Test in the Assessment of Mild Traumatic Brain Injury (mTBI), in Subjects With a Glasgow Coma Scale (GCS) Between 13-15
- ClinicalTrials.gov ID
- NCT06449183
- Acronym / sponsor ID
- BM-2023-12
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Mild Traumatic Brain Injury, mTBI, TBI, Biomarkers, Automated assays, Ubiquitin Carboxy-terminal Hydrolase-L1 (UCH-L1), Glial Fibrillary Acidic Protein (GFAP), Canadian CT Head Rule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Study start
- 16 May 2024 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Decision Rules for an initial CT-scan in patients arriving to Emergency Department (ED) and presenting a mild traumatic brain injury could be optimized by the use of an objective parameter easily and rapidly measured. This may be the place for serum biomarkers providing a quick and accurate assessment. BioMérieux has now developed an automated assay for the measurement of serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1), the VIDAS® TBI assay to fill out this unmet needs. The goal of the herein study is to generate real-world data and evidences to support the VIDAS® TBI performances.
Detailed description
The assessment of severity of TBI patients is based on the Glasgow Coma Scale (GCS) and the initial management in the ED includes performing a non-contrast brain Computed Tomography (CT) scan if the patient meets specific conditions. To date, real world data show that EDs would actually not follow guideline recommendations and a substantial CT overuse is observed. Management strategies are becoming more and more focused on selective CT use to effectively manage health care resources. Efforts have been made to optimize the indications for brain CT scan after mTBI. Although brain CT scan plays a central role after mTBI, there is an unmet clinical need for an objective tool to optimize indications for CT scan, reduce patient radiation exposure, and possibly predict patient outcome. Clinical Decision Rules for an initial CT-scan could be optimized by the use of an objective parameter easily and rapidly measured. This may be the place for serum biomarkers providing a quick and accurate assessment. BioMérieux has now developed an automated assay for the measurement of serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1), the VIDAS® TBI assay to fill out this unmet needs. The goal of the herein study is to generate real-world data and evidences to support the VIDAS® TBI performances.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Prospective Cohort. Multicentric, International clinical study.
| Arm | Type | Receives |
|---|---|---|
| Subjects with Mild Traumatic Brain injury | Experimental | Diagnostic Test: VIDAS® TBI Test [GFAP and UCH-L1 assays]Subjects presenting to the ED within 12 hours of suspected mild head trauma and a Glasgow Score of 13-15 undergo to blood collection for VIDAS® TBI [GFAP, UCH-L1] testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult subject ≥ 18 years old
- Subject with a Glasgow Coma Scale (GCS) score between 13-15 on admission
- Subject presenting to the Emergency Department for suspected mild Traumatic Brain Injury
- Subject with a non-contrast head Computed Tomography (CT) scan ordered per the clinical site's care usual care
- Blood sampling possible within 12 hours of injury (1 tube of 4-5 mL of blood)
Key exclusion criteria (6 listed)
- Time of injury unknown
- Subject with non-traumatic neurological disorders (e.g, dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, spontaneous intracranial haematoma)
- Neurosurgery, stroke or transient ischemic attack within the last 30 days
- Subject with an active cancer
- Subject with penetrating head injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIDAS® TBI Test [GFAP and UCH-L1 assays]The VIDAS® TBI (GFAP, UCH-L1) test is composed of two automated assays - VIDAS® TBI (GFAP) and VIDAS® TBI (UCH-L1) - to be used on the VIDAS® family of instruments for the quantitative measurement of Glial 15 Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase- L1 (UCH-L1) in human serum using the Enzyme Linked Fluorescent Assay (ELFA) technique. The results of both assays are required to obtain an overall qualitative test interpretation. | Diagnostic test | Subjects with Mild Traumatic Brain injury |
Primary outcome
To determine VIDAS® TBI sensitivity to exclude the presence of an intracranial lesion
Time frame: 12 hours post mild brain trauma
To determine VIDAS® TBI specificity to exclude the presence of an intracranial lesion
Time frame: 12 hours post mild brain trauma
To determine VIDAS® TBI Positive Predictive Value to exclude the presence of an intracranial lesion
Time frame: 12 hours post mild brain trauma
To determine VIDAS® TBI Negative Predictive Value to exclude the presence of an intracranial lesion
Time frame: 12 hours post mild brain trauma
To determine VIDAS® TBI Positive Likelihood Ratio to exclude the presence of an intracranial lesion
Time frame: 12 hours post mild brain trauma
To assess VIDAS® TBI Negative Likelihood Ratio to exclude the presence of an intracranial lesion
Time frame: 12 hours post mild brain trauma
15 secondary outcomes
To determine Canadian CT Head Rule specificity combined to VIDAS specificity to exclude the presence of an intracranial lesion
Time frame: 12 hours post mild brain trauma
To determine Canadian CT Head Rule sensitivity combined to VIDAS sensitivity to exclude the presence of an intracranial lesion
Time frame: 12 hours post mild brain trauma
To determine Canadian CT Head Rule Positive Predictive Value combined to VIDAS positive Predictive Value to exclude the presence of an intracranial lesion
Time frame: 12 hours post mild brain trauma
To determine Canadian CT Head Rule Negative Predictive Value combined to VIDAS Negative Predictive Value to exclude the presence of an intracranial lesion
Time frame: 12 hours post mild brain trauma
To determine Canadian CT Head Rule Negative Likelihood Ratio combined to VIDAS Negative Likelihood Ration to exclude the presence of an intracranial lesion
Time frame: 12 hours post mild brain trauma
To determine Canadian CT Head Rule Positive Likelihood Ratio combined to VIDAS Positive Likelihood Ration to exclude the presence of an intracranial lesion
Time frame: 12 hours post mild brain trauma
To estimate the impact of the use of VIDAS® TBI on the time to discharge
Time frame: 3 months
To estimate the expected impact of the use of VIDAS® TBI on patient stay in the ED
Time frame: 3 months
To estimate the expected impact of the use of VIDAS® TBI on hospitalization decision
Time frame: 3 months
To estimate the expected impact of the use of VIDAS® TBI on time to medical decision
Time frame: 3 months
To estimate the impact of the use of VIDAS® TBI on the patient's monitoring duration
Time frame: 3 months
to measure the percentage of CT-scan potentially avoided
Time frame: 3 months
To estimate the saving costs when using VIDAS® TBI in comparison with usual clinical sites' care.
Time frame: 3 months
To estimate the costs of Length of stay in Emergency Department (ED) when using VIDAS® TBI in comparison with usual clinical sites' care.
Time frame: 3 months
To estimate the associated costs of Length of stay in the hospital when using VIDAS® TBI in comparison with usual clinical sites' care.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIDAS® TBI Test [GFAP and UCH-L1 assays] in people with Mild Traumatic Brain Injury, run by BioMérieux at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine VIDAS® TBI sensitivity to exclude the presence of an intracranial lesion (time frame: 12 hours post mild brain trauma). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.