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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: Normal Saline Flush; Drug: Ferinject

• Registration Number: NCT04898569
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

* Perioperative blood loss and iatrogenic hemodilution lead to postoperative anemia which correlates with infections, and poor physical function, mobility and recovery with subsequent increases in the length of hospital stay and mortality. Preoperative anemia management reduce intraoperative blood loss such as normothermia, antifibrinolytics and cell salvage are key strategies to ameliorate postoperative anemia.

* Patient screening method Off-pump coronary artery bypass (OPCAB) under median-sternotomy, or minimal invasive direct coronary bypass (MIDCAB) undertaken under median-sternotomy Among them, the selection/exclusion criteria are checked and the subjects of the study are screened. \* Inclusion/ exclusion criteria \*\*Inclusion:

* Patients with Preoperative iron deficiency anemia Among Patients scheduled for cardiopulmonary coronary artery bypass graft under median sternotomy in cardiovascular surgery \*\*Exclusion: - a) Patients who underwent iron correction treatment (oral, injection, blood transfusion) within 2 months prior to surgery b) Patients taking anticoagulants before surgery c) Patients taking and administering drugs that can cause bone marrow suppression, such as anticancer drugs, before surgery d) Patients with chronic liver disease and chronic kidney disease undergoing dialysis e) Patients scheduled for coronary artery bypass graft for emergency surgery f) Patients with a history of hypersensitivity reactions and side effects to iron drugs g) Minor (under 20 years old) 3) 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 \* The primary goal of this study was the effect of intravenous administration of ferric carboxymaltose on postoperative hemoglobin levels in patients with preoperative iron deficiency anemia among patients requiring cardiopulmonary coronary artery bypass grafting due to coronary artery disease. It is to analyze the effect compared to the control.

Study Timeline

• Study Start: 2019-02-10
• Status Verified: 2021-05
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-21
• Last Update Submitted: 2021-05-21
• Study First Posted: 2021-05-24
• Last Update Posted: 2021-05-24
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal Saline Flush	-
Ferinject®	Ferinject	-

Primary Outcome Measures

Name	Time	Method
Total mediastinal blood loss and transfusion counts	At admission periods for Off-Pump Coronary Artery Bypass or Minimally Invasive Direct Coronary Artery Bypass surgery (Mean 8~9 days)	For cost-effectiveness analysis of ferric carboxymaltose in preoperative iron treatment

Secondary Outcome Measures

Name	Time	Method
rate of surgical revision for bleeding	intraoperative
rate of postoperative morbidity	Participants will be followed during 1 years from operation
amount of blood products transfused both intraoperatively and postoperatively	24 hours later after surgery
total length of intensive care unit (ICU) stay	mean 3-4 days
rate of postoperative mortality	Participants will be followed during 1 years from operation
blood loss in the operative day	24 hours later after surgery

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of