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

Study Overview
=================
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) 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.

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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Ferinject
* Drug: Normal Saline Flush


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferinject®<br> | Drug: Ferinject<br>* Ferric carboxymaltose injection<br>* Other names: Colloidal solution of the iron complex ferric carboxymaltose;|
| Placebo Comparator: Normal saline<br> | Drug: Normal Saline Flush<br>* placebo<br>* Other names: placebo comparator;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood transfusion, Coronary artery bypass surgery, Hemostasis, Iron therapy, Bleeding