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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT01228305
Eligibility Criteria:
Patients will be eligible for enrollment based on the following inclusion criteria:
1\) Infants or children (newborn to 17years of age) undergoing cardiopulmonary bypass for biventricular surgical correction of their congenital heart lesions.
Patients will not be eligible for this study based on the following exclusion criteria:
1. Patients scheduled for single ventricle palliation will be excluded, in an effort to standardize the time of repair, time on CPB, and surgical procedure.
2. Patients with severe neurological abnormalities at baseline.
3. Patients with major non-cardiac congenital malformations, developmental disorders or serious chronic disorders. Benign congenital malformations (such as club foot, ear tags, etc.) will not exclude the subject from the study.
4. Non-English speaking patients, or parent/legal guardians.
5. Patients less than 3 kg, to limit risk of excessive blood loss from lab draws.
6. Previous adverse reaction to acetaminophen
7. History of acute or chronic kidney disease
8. History of chronic liver disease
9. Emergency surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
17 Years
Study:
NCT01228305
Study Brief:
Protocol Section:
NCT01228305