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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT02540434
Eligibility Criteria:
Inclusion Criteria:
1. All subjects age 18 and older who have given written informed consent
2. Undergoing cardiac surgery cardiopulmonary bypass (CBP) at Weill Cornell Medical Center
Exclusion Criteria:
1. Subjects on anticoagulation medications including:
* Clopidogrel, ticagrelor, prasugrel with platelet function analyzer-100 assay closure time (CT) prolonged greater than 15%
* Last doses of dabigatran, rivaroxaban, apixaban within 72 hours
* Warfarin with international normalized ratio (INR) greater than 1.5
2. Positive pregnancy test, pregnancy or lactation
3. Thrombocytopenia: platelet count less than 100,000 u/L
4. Emergency procedures
5. Proof or suspicion of a congenital or acquired coagulation disorder (e.g. von Willebrand Factor or via severe liver disease)
6. Participation in another randomized clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02540434
Study Brief:
Protocol Section:
NCT02540434