Clinical trial NCT02855034: Evaluation of Discriminating Power of Two Biomarkers in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children
Official title: Evaluation of Discriminating Power of Two Biomarkers (Protein S100B/Copeptin) in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: child and infant
Blood samples
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 265
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Copeptin dosage
timeFrame: At the inclusion
Secondary outcomes:
measure: S100B protein dosage
timeFrame: At the inclusion
measure: GFAP protein dosage
timeFrame: At the inclusion
measure: NFL protein dosage
timeFrame: At the inclusion
measure: Tau dosage
timeFrame: At the inclusion
measure: UCHL-1 dosage
timeFrame: At the inclusion
measure: Combinaison of Copeptine, PS-100B, GFAP, Tau and UCHL-1 protein dosage
timeFrame: At the inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: Montpellier University Hospital
name: Gaëlle TOURNIAIRE, MD
role: PRINCIPAL_INVESTIGATOR
References: