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:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT01648712
Eligibility Criteria:
Inclusion Criteria:
* Infants/children (weighting less than 18 Kg) undergoing surgical repair of congenital heart defects on CPB, presenting a saturation \> 85% preoperatively.
Exclusion Criteria:
* Newborns, infants/children with Down syndrome, other syndromes or chromosomal abnormalities prematurity,
* use of circulatory arrest,
* expected perfusion time \< 1 hour, documented coagulation disorders, use of anticoagulant or antiplatelet drugs within 48 hours of surgery, previous heart surgery and procedures requiring a return on CPB (2 or more CPB runs),
* cyanosis defined as oxygen saturation lower than 85%.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Days
Maximum Age:
5 Years
Study:
NCT01648712
Study Brief:
Protocol Section:
NCT01648712