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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898569
• Other study ID #: 4-2018-0371
• Status: Recruiting
• Phase: Phase 4
• Start date: February 10, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2021
• Source: Yonsei University
• Contact: Young-Nam Youn
• Phone: 82-10-9930-4522
• Email: ysgs[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Coronary Artery Disease

Intervention

Drug:
• Ferinject
Ferric carboxymaltose injection
• Normal Saline Flush
placebo

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Banerjee S, McCormack S. Intravenous Iron Preparations for Patients Undergoing Elective Surgery: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Mar 27. Available from http://www.ncbi.nlm.nih.gov/books/NBK545893/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total mediastinal blood loss and transfusion counts	For cost-effectiveness analysis of ferric carboxymaltose in preoperative iron treatment	At admission periods for Off-Pump Coronary Artery Bypass or Minimally Invasive Direct Coronary Artery Bypass surgery (Mean 8~9 days)
Secondary	blood loss in the operative day		24 hours later after surgery
Secondary	amount of blood products transfused both intraoperatively and postoperatively		24 hours later after surgery
Secondary	rate of surgical revision for bleeding		intraoperative
Secondary	total length of intensive care unit (ICU) stay		mean 3-4 days
Secondary	rate of postoperative morbidity		Participants will be followed during 1 years from operation
Secondary	rate of postoperative mortality		Participants will be followed during 1 years from operation

External Links

•   Iron (Ferric) Carboxymaltose Infusion (FERINJECT®)