Using combined iron supplements to reduce blood transfusions in heart surgery patients

Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy in Anemic Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial

This study is testing if a mix of iron supplements and vitamin C can help heart surgery patients with low iron levels need fewer blood transfusions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06968936 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine if a combined regimen of intravenous sucrose iron, subcutaneous erythropoietin, and intravenous 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 associated with the treatment. Follow-up assessments will occur at various time points 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: Previous studies have shown promising results with iron supplementation in similar contexts, suggesting potential for success in this approach.

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

• Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Qi Gao, Dr.

Conditions Anemia; Iron Deficiencies; Cardiac Surgery