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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT02485366
Eligibility Criteria:
Inclusion Criteria:
* children greater than 2.5 kg and less than 15kg (i.e. requiring blood for CPB prime)
* children undergoing cardiac surgery with cardiopulmonary bypass
Exclusion Criteria:
* refusal of blood products
* end-stage renal disease
* planned avoidance of CPB
* use of non- heparin anticoagulants
* participation in an experimental drug or device protocol within 30 days
* existing hemoglobinopathy
* allergy requiring washed RBCs
* immunocompromise requiring special blood product treatment.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT02485366
Study Brief:
Protocol Section:
NCT02485366