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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT01461902
Eligibility Criteria:
Inclusion Criteria:
1. admission to Duke University Children's Hospital;
2. age 5 days to 15 years;
3. a diagnosis of a TBI with a GCS 3-15;
4. capable of adequate TCD ultrasound examination;
5. and presence of intravenous or arterial access (blood) and/or an EVD for cerebrospinal fluid (CSF) and/or Foley catheter/ability to void unassisted (urine) biomarker collection unless they are excluded based on the exclusion criteria.
Exclusion Criteria:
* the presence of previously diagnosed significant neurodevelopmental delay,
* a diagnosis of non-traumatic intracranial hemorrhage and
* parents/legal guardians who do not speak or understand English.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Days
Maximum Age:
15 Years
Study:
NCT01461902
Study Brief:
Protocol Section:
NCT01461902