Evaluation of Discriminating Power of Two Biomarkers in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children

Study Overview
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Brief Summary
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Head injury is a frequent motive of consultation in paediatric emergency units and the first cause of mortality in infants of more than one year old in developped countries. The indication of performing cerebral CT scans currently depends on clinical decision based on recommendations used in adults. In this way, 60 to 90% of scans are normal in children with head injury. CT scan is expensive and irradiating with the risk of increasing the cancer in children. Protein S100B and copeptin are biomarkers which have shown their ability to detect cerebral lesion in children with head injury. (protein S100B and /or in adults protein S100B and copetin). It is the first clinical biological evaluation of severity of head injury based on dosing of copeptin alone or associated with protein S100B. Furthermore, the evaluation of the biomarkers GFAP, NFL, Tau and UCHL-1 is today necessary from a scientific point of view and to optimize the diagnostic and prognostic value of these biomarkers which can be combined. Indeed, these protein biomarkers are biologically linked to the protein S100B and copeptin, and will allow a more specific and more thorough evaluation of the presence of brain damage at the cellular level. More specifically, the measurement of the S-100B and GFAP proteins will allow evaluation of gliovascular damage while those of copeptin, NFL, Tau and UCHL1 proteins will allow evaluation of neuronal damage. The assay of these different biomarkers will also be carried out on a control population, without head injury or neurological or inflammatory pathologies, in order to establish the standards of these biomarkers on a pediatric population of similar age.

Detailed Description
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265 children or infants will be recruited during 84 months. 220 patients with a suspicion of head injury and 45 patients without head injury. Each patient will attend a visit of inclusion and a blood sample. Just patients with a suspicion of head injury have a visit at 96 hours +/- 24 hours after the inclusion: this visit is made by phone. The patient and his parents will have to answer to a phone questionnaire

Official Title
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Evaluation of Discriminating Power of Two Biomarkers (Protein S100B/Copeptin) in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Other: Blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for the Target Population: Paediatric patients aged 3 months up to 15 years Cranial trauma with indication of brain scanner according to risk of clinically important traumatic brain injury (high or intermediate risk), according the clinical prediction rule Pediatric Emergency Care Applied Research Network (PECARN) Period of 6 hours of less after cranial trauma Informed and written consent from one of the parents or legal representatives Patient must be covered by a french social security scheme Inclusion criteria for the Control Population: Paediatric patients aged 3 months up to 15 years admitted to the emergency room for whom a blood sample is required Informed and written consent from one of the parents or legal representatives Patient must be covered by a french social security scheme Exclusion criteria for the Target Population: A pre-existing intracranial injury or malformation, or osteogenesis imperfecta Coagulation disorder Multiple accidental trauma Evocative elements of mistreatment Exclusion criteria for the Control Population: Cranial trauma ou suspicion of cranial trauma brain pathology including migraines Febrile syndrome Chronic inflammatory pathology Known bleeding disorder Evocative elements of mistreatment

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Blood sample<br>All the patients performed the same blood samples for dosage: copeptin, S-100B, GFAP, NFL and UCHL-1 proteins | Other: Blood samples<br>* Blood samples for dosage: copeptin and protein S100B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Copeptin dosage | Dosage of copeptin to determine the copeptin's performance in diagnostic of traumatic brain injury | At the inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S100B protein dosage | Dosage of protein S100B to determine this protein's performance in diagnostic of traumatic brain injury | At the inclusion | 
| GFAP protein dosage | Dosage of GFAP protein to determine this protein's performance in diagnostic of traumatic brain injury | At the inclusion | 
| NFL protein dosage | Dosage of NFL protein to determine this protein's performance in diagnostic of traumatic brain injury | At the inclusion | 
| Tau dosage | Dosage of Tau protein to determine this protein's performance in diagnostic of traumatic brain injury | At the inclusion | 
| UCHL-1 dosage | Dosage of UCHL-1 protein to determine this protein's performance in diagnostic of traumatic brain injury | At the inclusion | 
| Combinaison of Copeptine, PS-100B, GFAP, Tau and UCHL-1 protein dosage | Combination of these biomarkers to improve early discrimination of patients with brain injury secondary to CT. | At the inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child and infant, Blood samples