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Completed

NCT Number: NCT05425251

BRAINI-2 Elderly Mild TBI European Study

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GFAP and UCH-L1

Diagnostic 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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitario 12 de Octubre

Other

Collaborators

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

Registry information

Official study title

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

Acronym: BRAINI2ELDER

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 21, 2022
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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