Clinical trial NCT04898569: Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response and Transfusion in Patients With Iron Deficiency Anemia After Off-Pump Coronary Artery Bypass Grafting
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Bleeding
Blood transfusion
Coronary artery bypass surgery
Hemostasis
Iron therapy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Total mediastinal blood loss and transfusion counts
timeFrame: At admission periods for Off-Pump Coronary Artery Bypass or Minimally Invasive Direct Coronary Artery Bypass surgery (Mean 8~9 days)
Secondary outcomes:
measure: blood loss in the operative day
timeFrame: 24 hours later after surgery
measure: amount of blood products transfused both intraoperatively and postoperatively
timeFrame: 24 hours later after surgery
measure: rate of surgical revision for bleeding
timeFrame: intraoperative
measure: total length of intensive care unit (ICU) stay
timeFrame: mean 3-4 days
measure: rate of postoperative morbidity
timeFrame: Participants will be followed during 1 years from operation
measure: rate of postoperative mortality
timeFrame: Participants will be followed during 1 years from operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Division of Cardiovascular Surgery, Severance Cardiovascular Hospital, Yonsei University College of Medicine
name: Young-Nam Youn
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/