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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT01248104
Eligibility Criteria:
Inclusion Criteria:
1. Is the subject 18 years of age or older?
2. Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)?
3. Is the subject more than 30 kg ( 66 lbs)?
4. Does subject understand English?
Exclusion Criteria:
1. Does the subject have existing coagulation defects (INR \> 1.5, platelets \< 100 ?
2. Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ?
3. Does the subject have severe liver disease (AST \& ALT\> 3x normal) ?
4. Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery?
5. Is the subject having any procedure where CPB is not anticipated?
6. Is the patient weight greater than 150 kg?
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01248104
Study Brief:
Protocol Section:
NCT01248104