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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
2,880
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
Brest University Hospital
Brest, France
NOT_YET_RECRUITINGClermont-Ferrand University Hospital
Clermont-Ferrand, France
NOT_YET_RECRUITINGLouis Mourier Hospital (AP-HP)
Colombes, France
NOT_YET_RECRUITINGGrenoble University Hospital
Grenoble, France
NOT_YET_RECRUITINGLa Roche/Yon Hospital
La Roche-sur-Yon, France
NOT_YET_RECRUITINGLille University Hospital
Lille, France
NOT_YET_RECRUITINGLimoges University Hospital
Limoges, France
NOT_YET_RECRUITINGLorient Hospital
Lorient, France
NOT_YET_RECRUITINGMontpellier University Hospital
Montpellier, France
NOT_YET_RECRUITINGNantes University Hospital
Nantes, France
RECRUITING...and 10 more locations
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
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.
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Day 0
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