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

University Hospital, Montpellier167 enrolled

Overview

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 UCH-L1 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 UCH-L1 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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 15 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Copeptin dosage

Dosage of copeptin to determine the copeptin's performance in diagnostic of traumatic brain injury

Time frame: At the inclusion

Secondary Outcomes

S100B protein dosage

Dosage of protein S100B to determine this protein's performance in diagnostic of traumatic brain injury

Time frame: At the inclusion

GFAP protein dosage

Dosage of GFAP protein to determine this protein's performance in diagnostic of traumatic brain injury

Time frame: At the inclusion

NFL protein dosage

Dosage of NFL protein to determine this protein's performance in diagnostic of traumatic brain injury

Time frame: At the inclusion

Tau dosage

Dosage of Tau protein to determine this protein's performance in diagnostic of traumatic brain injury

Time frame: At the inclusion

UCH-L1 dosage

Dosage of UCH-L1 protein to determine this protein's performance in diagnostic of traumatic brain injury

Time frame: At the inclusion

Combinaison of Copeptine, PS-100B, GFAP, Tau and UCH-L1 protein dosage

Combination of these biomarkers to improve early discrimination of patients with brain injury secondary to CT.

Time frame: At the inclusion

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes