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Mild Traumatic Brain InjuryBRAINI2ELDERNCT05425251

BRAINI-2 Elderly Mild TBI European Study

An observational study of Mild Traumatic Brain Injury, run by Hospital Universitario 12 de Octubre at 7 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Mild Traumatic Brain Injury
What is being tested?
GFAP and UCH-L1
How many people
2,297 participants
Where
7 sitesin 3 countries
Study dates
1 Mar 2022to 30 Mar 2025
Phase
Observational
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: 2370 participants suffering mild TBI; 480 non TBI participants.

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 16Show fewer
  • 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.

Trial locations and contacts

7 sites in 3 countries.

7 sites in 3 countries

France4 sites

  • CHU Clermont-Ferrand

    Clermont-Ferrand

  • CHU Grenoble-Alpes

    Grenoble

  • Hôpital Edouard HERRIOT

    Lyon

  • Hôpital Lyon Sud HCL

    Lyon

Other trials in France

Spain2 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

Other trials in Spain

Germany1 site

  • Klinikum rechts der Isar

    Munich

Other trials in Germany

About this study

Official title: 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.

Being tested
GFAP and UCH-L1
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GFAP and UCH-L1Diagnostic test

    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.

Study groups in NCT05425251
Study groupRoleWhat they receive
BRAINI2-ELDERLY DIAGNOSTIC & PROGNOSTIC2370 patients suffering mild Traumatic brain injury
Receives: Diagnostic Test: GFAP and UCH-L1
BRAINI2-ELDERLY REFERENCE480 non-tbi elderly reference patients
Receives: Diagnostic Test: GFAP and UCH-L1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biomarkers diagnostic performance

    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

    Measured: 12 hours after mild TBI

Secondary outcomes (7)

  1. Determination of the potential of the two biomarkers in predicting neurological symptoms after TBI

    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.

    Measured: 1 week and 3 months

  2. GFAP reference values

    GFAP serum level distribution in the non-TBI reference population, considering age and comorbidities.

    Measured: 1 Day, day of extraction of the sample

  3. UCHL-1 reference values

    UCHL-1 serum level distribution in the non-TBI reference population, considering age and comorbidities.

    Measured: 1 Day, day of extraction of the sample

  4. Determination of the potential of the two biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI

    Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Extended Glasgow Outcome Score (GOSE)

    Measured: 1 week and 3 months

  5. Determination of the potential of the two biomarkers in predicting quality of life assessed by Qolibri-OS after TBI

    Early and midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by Qolibri-OS

    Measured: 1 week and 3 months

  6. Determination of the potential of the two biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI

    Midterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by EQ-5D-5L

    Measured: 3 months

  7. Determination of the potential of the two biomarkers in depression symptoms assessed by PHQ-9 after TBI

    Midterm biomarker predictive performance in terms of predicting depression symptoms after mild TBI assessed by PHQ-9

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start1 Mar 2022
  3. Primary completion31 Dec 2024
  4. Study completion30 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425251
Sponsor's protocol ID
HU 12Octubre
Other IDs
EIT-HEALTH 220325
Acronym
BRAINI2ELDER
Status last verified
Dec 2025
First submitted
11 Mar 2022
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lagares A, Payen JF, Biberthaler P, Poca MA, Mejan O, Pavlov V, Viglino D, Sapin V, Lassaletta A, de la Cruz J; Braini2_elderly_investigators Collaborative group. Study protocol for investigating the clinical performance of an automated blood test for glial fibrillary acidic protein and ubiquitin carboxy-terminal hydrolase L1 blood concentrations in elderly patients with mild traumatic BRAIN Injury and reference values (BRAINI-2 Elderly European study): a prospective multicentre observational study. BMJ Open. 2023 Jul 17;13(7):e071467. doi: 10.1136/bmjopen-2022-071467.

    PubMed 37460257

Questions about this trial

What is this clinical trial studying?

An observational study of Mild Traumatic Brain Injury, run by Hospital Universitario 12 de Octubre at 7 sites in 3 countries.

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 6 inclusion and 16 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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France, Spain, Germany. 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?

Biomarkers diagnostic performance (time frame: 12 hours after mild TBI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05425251, which also lists 1 linked publication.

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 29 Dec 2025.

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