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

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04898569

Collaborator

(none)

100

Enrollment

Location

Arms

46.7

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Ferinject Drug: Normal Saline Flush	Phase 4

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)

Ferritin<300mcg/L
Transferrin saturation<25%
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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

In cardiac surgery, patients were randomized to receive Ferinject or placebo (n=50), respectively. The selected agent was intravenous infusion in general ward, preoperatively.In cardiac surgery, patients were randomized to receive Ferinject or placebo (n=50), respectively. The selected agent was intravenous infusion in general ward, preoperatively.

Masking:

Single (Participant)

Masking Description:

Patients were offered the allocated treatment for ferric carboxymaltose or not, using the block randomization system. The selected agent was infused to patients after randomization.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 10, 2019

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ferinject®	Drug: Ferinject Ferric carboxymaltose injection Other Names: Colloidal solution of the iron complex ferric carboxymaltose
Placebo Comparator: Normal saline	Drug: Normal Saline Flush placebo Other Names: placebo comparator

Arm

Intervention/Treatment

Experimental: Ferinject®

Drug: Ferinject

Ferric carboxymaltose injection

Other Names:

Colloidal solution of the iron complex ferric carboxymaltose

Placebo Comparator: Normal saline

Drug: Normal Saline Flush

placebo

Other Names:

placebo comparator

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients aged 19 years or older
undergoing elective OPCAB or MIDCAB surgery with multi-vessel coronary artery disease.

Exclusion Criteria:

Patients who underwent iron correction treatment (oral, injection, blood transfusion) within 2 months prior to surgery
Patients taking anticoagulants before surgery
Patients taking and administering drugs that can cause bone marrow suppression, such as anticancer drugs, before surgery
Patients with chronic liver disease and chronic kidney disease undergoing dialysis
Patients scheduled for coronary artery bypass graft for emergency surgery
Patients with a history of hypersensitivity reactions and side effects to iron drugs
Minor (under 20 years old)
Definition of iron deficiency anemia (if all criteria a to c in the following items are satisfied)
Ferritin<300mcg/L
Transferrin saturation<25%
Hb<12.0g/dL for women or Hb<13.0g/dL for men