BRAINI-2 Elderly Mild TBI European Study (BRAINI2ELDER)

December 21, 2025 updated by: Alfonso Lagares Gómez-Abascal, Hospital Universitario 12 de Octubre

Blood Biomarkers to Improve Management of Mild Traumatic BRAIN Injury in the Elderly

Mild traumatic brain injury (mTBI) is one of the most frequent emergencies in the elderly population. Despite most mTBI are managed with cranial computed tomography (CT), only 10% of CTs show lesions, determining CT overuse. The use of serum glial fibrillary acidic protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) have shown potential for ruling out the need for cranial CT. However evidence on biomarker use in mild TBI were not based on studies that included aged participants and patients with comorbidities for which biomarker levels could vary. This is why there is a need for a prospective study that assesses the predictive performance of these two biomarkers in the elderly population, both in elderly patients suffering mild TBI and in a reference population, including patients and participants with and without comorbidities.

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.
2297

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 Contact Backup

Study Locations

  • France
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand
      • Grenoble, France
        • CHU Grenoble-Alpes
      • Lyon, France
        • Hôpital Edouard Herriot
      • Lyon, France
        • Hôpital Lyon Sud HCL
  • Germany
      • Munich, Germany
        • Klinikum rechts der Isar
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
    • Madrid
      • Madrid, Madrid, Spain, 28041
        • Hospital Universitario 12 De 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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

2370 participants suffering mild TBI; 480 non TBI participants.

Description

Inclusion Criteria:

  • BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC:

    • Patients ≥65 years of age
    • Mild TBI (GCS 13-15 on admission) with indication of brain CT scan in the 12 hours after injury ;
    • Blood sample obtained ≤12 h after injury and CT scan preferably ≤6h from blood sample.

  • BRAINI2-ELDERLY REFERENCE:

    • Non TBI patients ≥65 years of age

Exclusion Criteria:

  • BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC:

    • Age below 65 years.
    • 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 from the trauma scene or prehospital management.
    • Venipuncture not feasible
    • No realization of brain CT-scan
    • Subject under judiciary control
    • Subject in inclusion period of a drug interventional study

  • BRAINI2-ELDERLY REFERENCE:

    • Subject in inclusion period of another drug interventional study
    • Patients harboring a brain tumor
    • Patients that have had a stroke or neurosurgical operation 1 month prior to the inclusion 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

  • 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.
BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC
2370 patients suffering mild Traumatic brain injury
Diagnostic test: GFAP and UCH-L1
2x5mL blood samples will be used to determine the performance of the automated VIDAS TBI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.
BRAINI2-ELDERLY REFERENCE
480 non-tbi elderly reference patients
Diagnostic test: GFAP and UCH-L1
2x5mL blood samples will be used to determine the performance of the automated VIDAS TBI 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
Biomarkers diagnostic performance
Time Frame: 12 hours after mild TBI
Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1 used separately and in combination to detect the presence or absence of intracranial lesions on CT scan
12 hours after mild 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 potential of the two biomarkers in predicting neurological symptoms after TBI
Time Frame: 1 week and 3 months
Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Neurological status at 1 week and 3 months after TBI and Rivermead post concussion questionnaire.
1 week and 3 months
GFAP reference values
Time Frame: 1 Day, day of extraction of the sample
GFAP serum level distribution in the non-TBI reference population, considering age and comorbidities.
1 Day, day of extraction of the sample
UCHL-1 reference values
Time Frame: 1 Day, day of extraction of the sample
UCHL-1 serum level distribution in the non-TBI reference population, considering age and comorbidities.
1 Day, day of extraction of the sample
Determination of the potential of the two biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI
Time Frame: 1 week and 3 months
Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Extended Glasgow Outcome Score (GOSE)
1 week and 3 months
Determination of the potential of the two biomarkers in predicting quality of life assessed by Qolibri-OS after TBI
Time Frame: 1 week and 3 months
Early and midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by Qolibri-OS
1 week and 3 months
Determination of the potential of the two biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI
Time Frame: 3 months
Midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by EQ-5D-5L
3 months
Determination of the potential of the two biomarkers in depression symptoms assessed by PHQ-9 after TBI
Time Frame: 3 months
Midterm biomarker predictive performance in terms of predicting depression symptoms after mild TBI assessed by PHQ-9
3 months

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.
Hospital Universitario 12 de Octubre

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.
University Hospital, Clermont-Ferrand
University Hospital, Grenoble
Technical University of Munich
Hospital Vall d'Hebron
BioMérieux
EIT Health

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.
  • Principal Investigator: Alfonso Lagares Gómez-Abascal, MD, PhD, Hospital Universitario 12 De Octubre

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.
March 1, 2022

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.
December 31, 2024

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.
March 30, 2025

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 11, 2022

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.
June 15, 2022

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.
June 21, 2022

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.
December 29, 2025

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.
December 21, 2025

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.
December 1, 2025

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.
  • HU 12Octubre
  • EIT-HEALTH 220325 (Other Grant/Funding Number: European Institute of Innovation and Technology - EU co-fund)

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

product manufactured in and exported from the U.S.

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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