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 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT02939794
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 and older
2. Patient candidates for open heart surgery (coronary artery bypass, valve replacement, or a combination of both).
3. Hemoglobin above 12g/dL in women and above than 13g\\dL in men.
Exclusion Criteria:
1. Patients who require emergency heart surgery.
2. Patients who are not hemodynamically stable or intubated pre-operatively.
3. Patients with a known sensitivity to iron.
4. Patients with a known history of allergies (rashes, etc.).
5. Patients with liver failure (alanine aminotransferase\> 3 times normal).
6. Patients with cirrhosis.
7. Patients with an active infection.
8. Patients with rheumatoid arthritis and indications of an active infection.
9. Pregnant women.
10. Lactating women.
11. Patients with anemia prior to surgery for any reason (B12 deficiency or folic acid deficiency).
12. Patients participating in another drug trial.
13. Patients treated with iron who took medication within the four weeks prior to surgery.
14. Patients who received a blood transfusion in the four weeks prior to surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02939794
Study Brief:
Protocol Section:
NCT02939794