Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response and Transfusion in Patients With Iron Deficiency Anemia After Off-Pump Coronary Artery Bypass Grafting

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In this prospective open-label randomized tral, 100 patients with elective off-pump coronary artery bypass (OPCAB) or minimal invasive direct coronary bypass (MIDCAB) surgery were enrolled. Before surgery, if a patient had iron deficiency anemia, the patient was randomized to receive Ferinject®(Ferric carboxymaltose, n=50) or placebo (normal saline, n=50), respectively. A single dose should not exceed 1000mg of iron per day or 20mg per kg body weight. In addition, the administration of 1000mg of iron should not exceed once a week. Administration to patients with hemodialysis-dependent chronic kidney disease is once daily, and the maximum dose should not exceed 200 mg (4 ml) of iron. Patients weighing less than 35 kg should not exceed 500 mg total iron dose. It uses intravenous infusion and can be administered up to 1,000mg (20ml) as the maximum iron once. For intravenous infusion, this drug is diluted with 0.9% sterile physiological saline solution.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University

Criteria

Inclusion Criteria:

1. patients aged 19 years or older

2. undergoing elective OPCAB or MIDCAB surgery with multi-vessel coronary artery disease.

Exclusion Criteria:

1. Patients who underwent iron correction treatment (oral, injection, blood transfusion) within 2 months prior to surgery

2. Patients taking anticoagulants before surgery

3. Patients taking and administering drugs that can cause bone marrow suppression, such as anticancer drugs, before surgery

4. Patients with chronic liver disease and chronic kidney disease undergoing dialysis

5. Patients scheduled for coronary artery bypass graft for emergency surgery

6. Patients with a history of hypersensitivity reactions and side effects to iron drugs

7. Minor (under 20 years old)

8. Definition of iron deficiency anemia (if all criteria a to c in the following items are satisfied)

1. Ferritin<300mcg/L

2. Transferrin saturation<25%

3. Hb<12.0g/dL for women or Hb<13.0g/dL for men