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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT06781294
Eligibility Criteria:
Inclusion Criteria:
* Non emergent cardiac surgery requiring cardiopulmonary bypass with expected CPB time over 90 minutes (double valve replacement or valve replacement plus CABG).
* Written informed consent from patient or legal surrogates.
Exclusion Criteria:
* Transplant receptor.
* Advanced Chronic Kidney Disease (CKD 4 or 5).
* Renal replacement therapy in the last 90 days.
* Documented intolerance to study device.
* Inclusion in other ongoing study within the last 30 days.
* Pregnancy.
* Immunosuppressive treatment or steroids (prednisone \> 0.5 mg/kg/day or equivalent).
* Autoimmune disorder.
* Coexisting illness with a high probability of death (inferior to 6 months).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06781294
Study Brief:
Protocol Section:
NCT06781294