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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT03701620
Eligibility Criteria:
Inclusion Criteria:
* \<18 years
* admitted to the PICU at the CHUSJ
* moderate TBI (Glasgow Coma Scale (GCS): 9-12) or severe TBI (GCS ≤8) as - - assessed 30 minutes after TBI or upon arrival in the emergency room
* written parental consent.
Exclusion Criteria:
* children fulfilling brain death criteria at the time of PICU admission (GCS 3 and loss of all brain stem reflexes)
* children with a pacemaker or with previously diagnosed arrhythmia (HRV monitoring not reliable)
* inflicted trauma (different underlying pathophysiology)
* patients or parents who do not speak or read English or French.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
18 Years
Study:
NCT03701620
Study Brief:
Protocol Section:
NCT03701620