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Traumatic Brain InjuryBRAINI2NCT05413499

Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury

A study testing Biomarkers research in people with Traumatic Brain Injury, run by Nantes University Hospital at 20 sites in 4 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 (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… Read more about this study

Who is it for?
Ages 0 days to 18 years
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Biomarkers research
How many people
1,570 participants
Where
20 sitesin 4 countries
Study dates
2 Aug 2022to 26 May 2025
Phase
Interventional
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 0 days to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
  • 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
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  • 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
  • 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

Who cannot join

  • 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
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  • 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
  • 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

Trial locations and contacts

20 sites in 4 countries.

20 sites in 4 countries

France15 sites

  • Brest University Hospital

    Brest

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand

  • Louis Mourier Hospital (AP-HP)

    Colombes

  • Grenoble University Hospital

    Grenoble

  • La Roche/Yon Hospital

    La Roche-sur-Yon

  • Lille University Hospital

    Lille

  • Limoges University Hospital

    Limoges

  • Lorient Hospital

    Lorient

  • Montpellier University Hospital

    Montpellier

  • Nantes University Hospital

    Nantes

  • Armand Trousseau hospital (AP-HP)

    Paris

  • Robert Debré Hospital (AP-HP)

    Paris

  • Rennes University Hospital

    Rennes

  • Saint Etienne University Hospital

    Saint-Etienne

  • Saint Nazaire Hospital

    Saint-Nazaire

Other trials in France

Spain3 sites

  • Hospital Universitari Vall d'Hebron (ICS)

    Barcelona

  • Hospital 12 de Octubre

    Madrid

  • Hospital Infantil Universitario Nino Jesus

    Madrid

Other trials in Spain

Germany1 site

  • Klinikum rechts der Isar, Technical University of Munich

    Munich

Other trials in Germany

Switzerland1 site

  • Luzerner Kantonsspital

    Lucerne

Other trials in Switzerland

About this study

Official title: 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.

Being tested
Biomarkers research
Keywords
TBI / Biomarkers / paediatric
Medical subject headings
Brain Injuries, Traumatic

What participants receive

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

  • Biomarkers researchOther

    For a part of the included population, the children with a mTBI and without indication of CT scan, a non-routine blood sample will be planned

What is being measured

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

  1. 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

    Measured: Day 0

Secondary outcomes (6)

  1. Prediction of early and mid-term prognosis after TBI : Number of participants with Early clinical worsening

    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.

    Measured: 72 hours after TBI

  2. Prediction of early and mid-term prognosis after TBI : Glasgow Outcome Scale-Extended, paediatric version (GOS-E Peds)

    Neurological outcome: Glasgow Outcome Scale-Extended, paediatric version (GOS-E Peds)

    Measured: Month 1, Month 3

  3. Prediction of early and mid-term prognosis after TBI : ost-concussion symptoms: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

    Post-concussion symptoms: Rivermead Post-Concussion Symptoms Questionnaire (RPQ)

    Measured: Month 1, Month 3

  4. Prediction of early and mid-term prognosis after TBI : Health related quality of life: PedsQL questionnaire

    Health related quality of life: PedsQL questionnaires

    Measured: Month 1, Month 3

  5. Prediction of early and mid-term prognosis after TBI : Serum GFAP and UCH-L1 concentrations

    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)

    Measured: Day 0

  6. Establishment of age-appropriate physiological reference values

    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

    Measured: Day 0

Timeline

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

  1. First posted10 Jun 2022
  2. Study start2 Aug 2022
  3. Primary completion26 May 2025
  4. Study completion26 May 2025

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,570 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05413499
Sponsor's protocol ID
RC21_0595
Acronym
BRAINI2
Status last verified
Jun 2026
First submitted
1 Jun 2022
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lorton F, Lagares A, de la Cruz J, Mejan O, Pavlov V, Sapin V, Poca MA, Lehner M, Biberthaler P, Chauvire-Drouard A, Gras-Le-Guen C, Scherdel P; BRAINI-2 paediatric Collaborative group; Collaborators. Performance of glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) biomarkers in predicting CT scan results and neurological outcomes in children with traumatic brain injury (BRAINI-2 paediatric study): protocol of a European prospective multicentre study. BMJ Open. 2024 May 15;14(5):e083531. doi: 10.1136/bmjopen-2023-083531.

    PubMed 38754888

Questions about this trial

What is this clinical trial studying?

A study testing Biomarkers research in people with Traumatic Brain Injury, run by Nantes University Hospital at 20 sites in 4 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 15 inclusion and 20 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France, Spain, Germany, Switzerland. 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?

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). 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 NCT05413499, 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 3 Jun 2026.

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