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NCT05413499
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Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

0 Days - 18 Years

Study Type

INTERVENTIONAL

Enrollment

1570

Start Date

2022-08-02

Completion Date

2025-05-26

Last Updated

2026-06-03

Healthy Volunteers

No

Interventions

OTHER

Biomarkers research

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

Locations (20)

Brest University Hospital

Brest, France

Clermont-Ferrand University Hospital

Clermont-Ferrand, France

Louis Mourier Hospital (AP-HP)

Colombes, France

Grenoble University Hospital

Grenoble, France

La Roche/Yon Hospital

La Roche-sur-Yon, France

Lille University Hospital

Lille, France

Limoges University Hospital

Limoges, France

Lorient Hospital

Lorient, France

Montpellier University Hospital

Montpellier, France

Nantes University Hospital

Nantes, France

Armand Trousseau hospital (AP-HP)

Paris, France

Robert Debré Hospital (AP-HP)

Paris, France

Rennes University Hospital

Rennes, France

Saint Etienne University Hospital

Saint-Etienne, France

Saint Nazaire Hospital

Saint-Nazaire, France

Klinikum rechts der Isar, Technical University of Munich

Munich, Germany

Hospital Universitari Vall d'Hebron (ICS)

Barcelona, Spain

Hospital 12 de Octubre

Madrid, Spain

Hospital Infantil Universitario Nino Jesus

Madrid, Spain

Luzerner Kantonsspital

Lucerne, Switzerland