Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT02855034
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
15 Years
Study:
NCT02855034
Study Brief:
Protocol Section:
NCT02855034