TerminatedNot Applicable

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

Stopped: Difficulties in recruiting control patients to the emergency department

France167 participantsStarted 2016-05-27

Plain-language 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 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.

Who can participate

Age range3 Months – 15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Copeptin dosage

Timeframe: At the inclusion

Trial details

NCT IDNCT02855034

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-10