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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarkers research | Other | 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 |
| Measure | Description | 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 | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
TBI population
Admission within 24 hours of the injury
Ability to follow-up by telephone, mail or email
For the mTBI group:
For the moderate or severe TBI group:
Non-TBI control paediatric population
Exclusion Criteria:
TBI population
Non-TBI control paediatric population
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| Name | Affiliation | Role |
|---|---|---|
| Fleur LORTON | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brest University Hospital | Brest | France | ||||
| Clermont-Ferrand University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38754888 | Derived | 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. |
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| 72 hours after TBI |
| 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) | Month 1, Month 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) | Month 1, Month 3 |
| Prediction of early and mid-term prognosis after TBI : Health related quality of life: PedsQL questionnaire | 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 | 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 | 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 |
| 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 |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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