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Blood Biomarkers to Improve Management of Children With Traumatic Brain Injury
Sponsor: Nantes University Hospital
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
Conditions
Interventions
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