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:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT00282269
Eligibility Criteria:
Inclusion Criteria:
* have a severe traumatic brain injury as defined by either a GCS ≤ 8 and an abnormal CT scan (intracranial hemorrhage, cerebral edema or diffuse axonal injury) or a motor score ≤ 3 and normal CT scan
* are aged between 1 and 16 years
* are mechanically ventilated
Exclusion Criteria:
* are not randomized by 6 hours after injury
* have penetrating brain injuries
* have fixed dilated pupils and GCS = 3
* have proven cervical spinal cord injury
* have more than mild neurodevelopmental disability prior to injury
* have an acute isolated epidural hematoma and are expected to recover rapidly after surgical removal
* have had a post-traumatic seizure with a normal CT scan
* have refractory shock, defined as systolic blood pressure more than 2 standard deviations (SD) below the mean for age despite 80ml/kg intravenous fluid resuscitation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
16 Years
Study:
NCT00282269
Study Brief:
Protocol Section:
NCT00282269