Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response and Transfusion in Patients With Iron Deficiency Anemia After Off-Pump Coronary Artery Bypass Grafting
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronary (Artery) Disease
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 (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
Participation Requirements
- Age
- Between 19 years and 85 years
- Gender
- Both males and females
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 los...
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.
Tracking Information
- NCT #
- NCT04898569
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Young-Nam Youn Division of Cardiovascular Surgery, Severance Cardiovascular Hospital, Yonsei University College of Medicine