Perioperative Blood Conservation: Role of Combined Iron Supplementation Protocols in Reducing Allogeneic Transfusion

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a special combination of iron supplements can help reduce the need for blood transfusions in adults with iron-deficiency anemia who are having major heart surgery. The researchers want to find out if this combination (which includes iron, a hormone that helps make red blood cells, and vitamin C) is safe and effective compared to standard treatment. They will monitor participants' blood needs during and after surgery, up to 90 days later.

To be eligible for this trial, participants must be 18 years or older and have certain types of heart surgery planned, like bypass surgery or valve surgery. They should also meet specific criteria related to their iron levels and overall health. Participants can expect to receive either the new iron treatment or standard care before their surgery and will be closely watched for any side effects or complications. This trial is a chance to potentially improve how anemia is managed in heart surgery, which could lead to better outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants must be at least 18 years of age.
• • 2. Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both.
• • 3. 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.
• • 4. The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3.
• • 5. Prior to participation, the patient or their legal representative must provide informed consent.
• Exclusion Criteria:
• • 1. Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO.
• • 2. Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics.
• • 3. Individuals with a weight equal to or less than 50kg.
• • 4. 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.
• • 5. Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc.
• • 6. Requirement for emergency surgical intervention.
• • 7. 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
• • 8. Pregnant or lactating women
• • 9. history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeks prior to surgery
• • 10. Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.