Skip to content

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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04898569
Enrollment
100
Registered
2021-05-24
Start date
2019-02-10
Completion date
2022-12-31
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Bleeding, Blood transfusion, Coronary artery bypass surgery, Hemostasis, Iron therapy

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.

Interventions

DRUGFerinject

Ferric carboxymaltose injection

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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.

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.

Eligibility

Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total mediastinal blood loss and transfusion countsAt 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

MeasureTime frame
amount of blood products transfused both intraoperatively and postoperatively24 hours later after surgery
rate of surgical revision for bleedingintraoperative
blood loss in the operative day24 hours later after surgery
rate of postoperative morbidityParticipants will be followed during 1 years from operation
rate of postoperative mortalityParticipants will be followed during 1 years from operation
total length of intensive care unit (ICU) staymean 3-4 days

Countries

South Korea

Contacts

Primary ContactYoung-Nam Youn
ysgs@yuhs.ac82-10-9930-4522

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026