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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT03576534
Eligibility Criteria:
Inclusion Criteria:
* All patients \< 8 kilograms and \< 1 year (to ensure that all patients receive steroids at initiation of CPB) undergoing an index cardiac operation for that hospitalization (using a single PBUF protocol)
Exclusion Criteria:
* Patients undergoing repeat cardiac surgery within the same admission
* Patients undergoing transplants as their index surgery
* Patients undergoing Ventricular assist device implantation as their index surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
1 Year
Study:
NCT03576534
Study Brief:
Protocol Section:
NCT03576534