BRAINI-2 Elderly Mild TBI European Study (BRAINI2ELDER)

October 15, 2023 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2850

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 Backup

Study Locations

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

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
Intervention / Treatment
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

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

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

Hospital Universitario 12 de Octubre

Collaborators

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

Investigators

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

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)

March 1, 2022

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

June 15, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 15, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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

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.

Clinical Trials on Mild Traumatic Brain Injury

Clinical Trials on GFAP and UCH-L1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe