Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury (BRAINI2)

June 2, 2026 updated by: Nantes University Hospital

BRAINI2-Paediatric : Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury: a European, Prospective, Multicentre Clinical Study

Mild traumatic brain injury (TBI), defined by a Glasgow Coma Scale (GCS) score of 13 to 15, is the cause of many consultations in paediatric emergency departments (1), even though it is a rare cause of acute complication: approximately 10% of children present with intracranial lesions (ICL) on the CT scan and less than 1% require neurosurgical intervention (2). Although ICLs remain a serious complication requiring rapid diagnosis, brain CT scans, the gold standard diagnostic test, cannot be performed routinely because many children would be unnecessarily exposed to ionising radiation associated with an increased risk of cancer (3). In recent years, several clinical decision rules for the management of mTBI have therefore been developed with the aim of identifying children at high or very low risk of ICL in order to better target CT scan indications. Despite this, the rate of CT scans performed has remained high, up to 35%, and has not decreased with the application of these clinical decision rules (4).

Furthermore, even though the majority of children and adolescents recover quickly after mTBI, nearly 30% will present symptoms such as headaches, dizziness, asthenia, memory, concentration or sleep disorders persisting beyond one month with a possible impact on their quality of life (5). Thus, there is a need to develop new strategies to (i) limit the use of CT scans while minimising the risk of late diagnosis of ICL, (ii) identify children with a higher risk of adverse outcome and/or post-concussive symptoms.

One of the most promising strategies is the use of brain-based blood biomarkers. This study therefore aims to provide new knowledge on two of them, GFAP and UCH-L1 (6,7), in particular by using an automated test combining them (the VIDAS® TBI test developed by bioMérieux) in order to improve the management of CT in the paediatric population at the diagnostic and prognostic levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1570

Phase

  • Not Applicable

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
      • Brest, France
        • Brest University Hospital
      • Clermont-Ferrand, France
        • Clermont-Ferrand University Hospital
      • Colombes, France
        • Louis Mourier Hospital (AP-HP)
      • Grenoble, France
        • Grenoble University Hospital
      • La Roche-sur-Yon, France
        • La Roche/Yon Hospital
      • Lille, France
        • Lille University Hospital
      • Limoges, France
        • Limoges University Hospital
      • Lorient, France
        • Lorient Hospital
      • Montpellier, France
        • Montpellier University Hospital
      • Nantes, France
        • Nantes University Hospital
      • Paris, France
        • Armand Trousseau hospital (AP-HP)
      • Paris, France
        • Robert Debré Hospital (AP-HP)
      • Rennes, France
        • Rennes University Hospital
      • Saint-Etienne, France
        • Saint Etienne University Hospital
      • Saint-Nazaire, France
        • Saint Nazaire Hospital
  • Germany
      • Munich, Germany
        • Klinikum rechts der Isar, Technical University of Munich
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron (ICS)
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Infantil Universitario Niño Jesús
  • Switzerland
      • Lucerne, Switzerland
        • Luzerner Kantonsspital

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

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Children and adolescents <18 years old Consent from one of the parents of the child or from holder of parental responsibility Consent from the child or adolescent Parental affiliation with an appropriate health insurance system

  1. TBI population

    • Admission within 24 hours of the injury
    • Ability to follow-up by telephone, mail or email

    • For the mTBI group:

      • GCS score of 13-15 on admission
      • Indication for cerebral CT scan according to national or local guidelines or the in-charge physician OR diagnosis of concussion consistent with the fourth Zurich consensus statement (9) . Concussion was defined as a complex pathophysiological process caused by a direct blow to the head, face, neck, or elsewhere on the body with an impulsive force transmitted to the head (which may or may not have involved loss of consciousness), resulting in a brain injury with one or more symptoms in one or more of the following clinical domains: somatic, cognitive, emotional or behavioural, or sleep. To objectively help diagnose concussion, the validated Acute Concussion Evaluation (ACE) questionnaire (10) for children with mTBI will be used, the presence of ≥ 1 symptom on the ACE defines concussion.

    • For the moderate or severe TBI group:

      • GCS score of 3-12 on admission
      • Indication for cerebral CT scan according to national or local guidelines or the in-charge physician

  2. Non-TBI control paediatric population

    • Admission for any reason other than TBI
    • Indication of blood sampling for their routine management
    • GCS score of 15
    • Otherwise healthy, i.e. without chronic pathology

Exclusion Criteria:

  1. TBI population

    • Time of injury unknown or exceeding 24 hours
    • Blood sampling not possible within 24 hours after the injury or 6 hours after the CT scan, if applicable
    • Penetrating brain injury with skull fracture
    • Pre-existing neurological disorders affecting the assessment of neurological outcome, seizure disorder/epilepsy, brain tumour, history of neurosurgery, stroke, encephalopathy
    • Venepuncture not feasible
    • Pregnant woman
    • Intoxication
    • No clear primary mechanism of trauma
    • No possibility for transferring CT scan images to the centralised platform in case of neuroimaging only performed in an outside hospital before transfer
    • Participation in another interventional research study

  2. Non-TBI control paediatric population

    • Pre-existing neurological disorders, seizure disorder/epilepsy, brain tumour, history or indication of neurosurgery, stroke, encephalopathy
    • History of TBI
    • Orthopaedic trauma or surgery within the last month
    • Suspected meningitidis or encephalitis
    • Venepuncture not feasible
    • Pregnant woman
    • Intoxication
    • Participation in another interventional research 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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 ICL on CT scan
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of early and mid-term prognosis after TBI : Number of participants with Early clinical worsening
Time Frame: 72 hours after TBI
Early clinical worsening defined by the occurrence of death from TBI, neurosurgical intervention, intubation for TBI, or hospital admission of two nights or more associated with ICL on CT scan for persistent neurological symptoms such as persistent alteration in mental status, recurrent emesis due to TBI, persistent severe headache, or ongoing seizure management (8), within 72 hours after TBI.
72 hours after TBI
Prediction of early and mid-term prognosis after TBI : Glasgow Outcome Scale-Extended, paediatric version (GOS-E Peds)
Time Frame: Month 1, Month 3
Neurological outcome: Glasgow Outcome Scale-Extended, paediatric version (GOS-E Peds)
Month 1, Month 3
Prediction of early and mid-term prognosis after TBI : ost-concussion symptoms: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Time Frame: Month 1, Month 3
Post-concussion symptoms: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
Month 1, Month 3
Prediction of early and mid-term prognosis after TBI : Health related quality of life: PedsQL questionnaire
Time Frame: Month 1, Month 3
Health related quality of life: PedsQL questionnaires
Month 1, Month 3
Prediction of early and mid-term prognosis after TBI : Serum GFAP and UCH-L1 concentrations
Time Frame: Day 0
Comparison of serum GFAP and UCH-L1 concentrations according to the TBI severity groups, i.e. mild (GCS score of 13-15), moderate (GCS score of 9-12) or severe (GCS score of 3-8)
Day 0
Establishment of age-appropriate physiological reference values
Time Frame: Day 0
Measure of serum GFAP and UCH-L1 concentrations in three age groups (under 2 years old, 2-9 years old and aged 10 and over) in a non-TBI control paediatric population
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Fleur LORTON, Nantes University Hospital

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)

August 2, 2022

Primary Completion (Actual)

May 26, 2025

Study Completion (Actual)

May 26, 2025

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 9, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC21_0595

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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