A Study of Biomarkers of Mild Traumatic BRAIN Injury (BRAINI)

February 28, 2022 updated by: University Hospital, Grenoble

A Prospective Clinical Study of Biomarkers of Mild Traumatic BRAIN Injury

Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

Study Overview

Status

Status

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

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 (Actual)

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.
1501

Contacts and Locations

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

Study Locations

  • France
      • Annecy, France
        • Centre Hospitalier Annecy Genevois
      • Bordeaux, France
        • CHU Bordeaux
      • Dijon, France
        • CHU Dijon
      • Grenoble, France
        • Chu Grenoble Alpes
      • Lyon, France
        • Hôpital Edouard Herriot - HCL
      • Lyon, France
        • Hôpital Lyon Sud HCL
      • Montpellier, France
        • Chu Montpellier
      • Nantes, France
        • Chu Nantes
      • Poitiers, France
        • CHU Poitiers
      • Toulouse, France
        • CHU Toulouse
      • Tours, France
        • CHU Tours
      • Villefranche-sur-Saône, France
        • Hopital Nord Ouest de Villefranche Sur Saone
  • Spain
      • Madrid, Spain
        • Hospital Gregorio Marañon
      • Madrid, Spain
        • Hospital de La Princesa
      • Madrid, Spain
        • Hospital del Tajo
      • Madrid, Spain
        • Hospital Universitario de 12 Octubre

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

1600 patients: 1300 patients in France and 300 patients in Spain

Description

Inclusion Criteria:

  • Patients >18 years old (France)
  • Mild TBI (GCS 13-15 on admission) within 12 hours after injury

  • Indication of brain CT scan:

    • neurological focal deficit
    • anterograde amnesia
    • Glasgow coma scale score <15 after 2 hours post-TBI
    • suspicion of vault depression fracture
    • fracture of the basal skull
    • persisting nausea, vomiting or headache
    • post-TBI seizures
    • Pre-injury treatment with antithrombotic drugs
    • Loss of consciousness or amnesia with age >65 years, fall >1m or hit pedestrian
    • Other condition requiring CT scan according to the in-charge physician.

Exclusion Criteria:

  • GCS 3-12 on admission
  • Time of injury unknown
  • Time to injury exceeding 12 hours
  • Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous intracranial hematoma)
  • Penetrating head trauma
  • Patient with mechanical ventilation
  • Pre-injury neurological disorder affecting the assessment of neurological outcome: dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumor, and history of neurosurgery, stroke or transient ischemic attack (TIA) within the last 30 days
  • Venipuncture not feasible
  • No realization of brain CT-scan
  • Subject under judiciary control
  • Pregnant or breastfeeding woman
  • Subject in exclusion period of another 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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.
Mild TBI
Mild TBI (GCS 13-15 on admission) within 12 hours after injury
Other: 2 x 5 mL blood sample
2 x 5 mL blood sample to determine the performance of the automated VIDAS BTI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.

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
Measure Description
Time Frame
Performance of the VIDAS-BTI assay in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and their corresponding lower limit of 95% confidence interval by comparison with brain CT scan findings.
Time Frame: 12 hours post Traumatic Brain Injury (TBI)
2 x 5mL blood sample
12 hours post Traumatic Brain Injury (TBI)

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
Measure Description
Time Frame
Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home
Time Frame: Admission
TCD measures at admission
Admission
Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home
Time Frame: 7 days after traumatic brain injury (TBI)
Neurological status at 1 week after TBI
7 days after traumatic brain injury (TBI)
Determination of the added value of the two biomarkers measurements to Transcranial Doppler (TCD) performed on admission to detect patients at risk of neurological worsening and patients allowed for a safe return home
Time Frame: 7 days after traumatic brain injury (TBI)
Quality of life after brain injury (QOLIBRI) Questionnaire
7 days after traumatic brain injury (TBI)
Determination the potential of the two biomarkers in predicting neurological outcome
Time Frame: 3 month after TBI
Extended Glasgow Outcome Scale (GOSE)
3 month after TBI
Determination of the potential of the two biomarkers in predicting neurological outcome
Time Frame: 3 month after TBI
Quality of life after brain injury (QOLIBRI) Questionnaire)
3 month after TBI
Determination of the potential of the two biomarkers in predicting neurological outcome
Time Frame: 3 month after TBI
EuroQuol 5 dimensions 5 level questionnaire (EQ-5D-5L)
3 month after TBI
Determination of the potential of the two biomarkers in predicting neurological outcome
Time Frame: 3 month after TBI
Rivermead Post-concussion symptoms Questionnaire (RPQ)
3 month after TBI

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.
University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
August 10, 2019

Primary Completion (Actual)

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.
June 30, 2021

Study Completion (Actual)

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.
September 28, 2021

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).
July 15, 2019

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.
July 22, 2019

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.
July 25, 2019

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.
March 2, 2022

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.
February 28, 2022

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.
August 1, 2020

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.
  • 38RC19.176
  • 2019-A01525-52 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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