Combined iron supplementation to reduce blood transfusions in cardiac surgery

Effect of Iron Sucrose Combined With Human Erythropoietin and Vitamin C on Perioperative Allogeneic Red Blood Cell Infusion in Major Cardiac Surgery

This study tests if a new combination of iron, a hormone, and vitamin C can help adults with iron-deficiency anemia needing heart surgery avoid blood transfusions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06012760 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine if a combined regimen of intravenous sucrose iron, human erythropoietin, and vitamin C can effectively reduce the need for blood transfusions in adults with iron-deficiency anemia undergoing major elective cardiac surgery. Participants will be randomly assigned to receive either the combined treatment or standard care before their surgery. The study will monitor the total volume of blood transfusions required during and after the surgery, as well as any potential side effects or safety concerns associated with the treatment. Follow-up assessments will occur up to 90 days post-surgery to evaluate recovery and transfusion needs.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with iron deficiency anemia scheduled for major cardiac surgery.

Not a fit: Patients who do not have iron deficiency anemia or those with contraindications to the study medications will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly decrease the reliance on blood transfusions during cardiac surgeries, improving patient outcomes and safety.

How similar studies have performed: While the specific combination of treatments is novel, similar studies have shown that iron supplementation can reduce transfusion needs in surgical settings.

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.

Where this trial is running

Hangzhou, Zhejiang

• The Second Affiliated Hospital of Zhejiang University anesthesiology department — Hangzhou, Zhejiang, China (RECRUITING)

Conditions: Anemia, Iron Deficiency Anemia, Perioperative, Transfusion, Cardiac Surgery