The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion (CIPAT)
Anemia, Iron Deficiency Anemia, Perioperative
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria: Participants must be at least 18 years of age. The initial elective 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. Prior to participation, the patient or their legal representative must provide informed consent. Exclusion Criteria: 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. Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc. Requirement for emergency surgical intervention. Severe hepatic or renal impairment, ALT >3 times the upper limit of normal value or AST >3 times the upper limit of normal value, creatinine >1.5 times the upper limit of normal value Pregnant or lactating women history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeks prior to surgery Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.
Sites / Locations
- The Second Affiliated Hospital of Zhejiang University anesthesiology departmentRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Intervention group
Control group
Preoperative randomization was conducted, followed by a three-day regimen in the week preceding surgery, involving the administration of intravenous iron sucrose at a dosage of 200 mg per day, vitamin C at a dosage of 2 g per day, and subcutaneous administration of Human Erythropoietin Injection at a dosage of 150 IU per kilogram.
Preoperative randomization was conducted, followed by the administration of 200 ml of saline via intravenous infusion and 1 ml of saline via subcutaneous injection for three consecutive days in the week preceding the surgery.