The goal of this clinical trial is to learn if a combined iron supplementation regimen can reduce the need for blood transfusions in adults with iron-deficiency anemia undergoing major elective cardiac surgery. The trial will also look at whether this regimen is safe and well tolerated. The main questions it aims to answer are:
Does the combined regimen lower the amount of allogeneic red blood cell transfusion needed during and after surgery?
Are there any side effects or safety concerns associated with the regimen?
Researchers will compare the combined iron supplementation (sucrose iron, erythropoietin, and vitamin C) to standard care to see if it helps reduce blood transfusions.
Participants will:
Receive either the combined regimen or standard care before surgery
Undergo major elective cardiac surgery under general anesthesia
Be monitored for blood transfusion needs and recovery up to 90 days after surgery
Participants must be at least 18 years of age.
Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both.
Iron deficiency anemia is defined as having a ferritin level below 100 μg/L or a ferritin level below 300 μg/L accompanied by a transferrin saturation below 25%. Additionally, hemoglobin levels should range between 90 and 130 g/L for men or between 90 and 120 g/L for women.
The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3.
Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO.
Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics.
Individuals with a weight equal to or less than 50kg.
Individuals with a family history of haemochromatosis or thalassaemia, or those with a transferrin saturation level exceeding 50% or a documented history of iron overload.
Parallel
Iron sucrose, Human Erythropoietin Injection, Vitamin C
DrugThe participants were administered a combined iron supplementation regimen consisting of iron sucrose,Human Erythropoietin Injection, and vitamin C, three times throughout the preoperative week.
Standard Medical Care
DrugStandard Medical Care (SMC) for the treatment of IDA. SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
Perioperative allogeneic red blood cell transfusion volume
The volume of allogeneic red blood cell transfusions during the perioperative period.
The quantity and percentage of allogeneic blood products utilized during the perioperative period.
This encompasses blood components such as plasma and platelets, erythrocytes.
The alterations in perioperative haemoglobin levels.
Haemoglobin levels were assessed at various time intervals.
The alterations in ferritin levels and TSAT during the perioperative period.
Ferritin and Transferrin Saturation values were assessed at various time intervals.
The alterations in reticulocyte levels during the perioperative period.
Reticulocyte levels were measured at various time intervals.
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
Collaborator
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Collaborator
The Central Hospital of Lishui City
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Zhejiang Provincial People's Hospital
Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Collaborator
Zhejiang University
Collaborator
Affiliated Hospital of Nanjing University of Chinese Medicine
Collaborator
