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:
NCT02428894
Eligibility Criteria:
Inclusion Criteria:
* Planned HeartMate II LVAD implantation
* Planned warfarin (goal INR, 2.0-3.0) and low-dose aspirin therapy post-LVAD placement
Exclusion Criteria:
* Prior history of mechanical circulatory support;
* Body weight \< 110 lbs;
* Pre-existing hemolytic, bleeding, or immunologic disorders prior to LVAD implantation;
* Severe aortic stenosis;
* Renal failure requiring dialysis;
* Hepatic dysfunction resulting in severe coagulopathies;
* Recent serious infection;
* Current need for prolonged ventilatory support;
* Prior organ transplantation;
* Blood transfusion within 14 days of the first planned study blood draw;
* Concomitant immunosuppressant or chemotherapeutic agents;
* Pregnant women;
* Decisionally challenged or prisoners;
* Unwilling to provide written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT02428894
Study Brief:
Protocol Section:
NCT02428894