Innovative treatment for perioperative anaemia in cardiac surgery patients

Effectiveness of Iron Sucrose Combined With rHuEPO and Ascorbic Acid in Improving Perioperative Anaemia in Patients Undergoing Major Cardiac Surgery

This study is testing a new combination treatment of iron, a hormone, and vitamin C to see if it can help people with low iron levels feel better before heart surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05353348 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates a combined treatment approach using iron sucrose, recombinant human erythropoietin, and vitamin C to address perioperative anaemia in patients undergoing elective major cardiac surgery. The study aims to enhance erythropoiesis and improve iron metabolism, offering a more comprehensive intervention compared to traditional single intravenous iron supplementation. By targeting multiple aspects of iron metabolism and erythropoiesis, this innovative strategy seeks to provide better outcomes for patients with iron deficiency anaemia. The trial includes patients with specific eligibility criteria related to their haemoglobin levels and iron status.

Who should consider this trial

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

Not a fit: Patients with known allergies to the study medications or those with chronic renal insufficiency or other specific exclusions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of perioperative anaemia, leading to better surgical outcomes for patients.

How similar studies have performed: While previous studies have focused on single intravenous iron supplementation, this combined approach is novel and has not been extensively tested in this specific context.

Eligibility criteria

Inclusion Criteria:

* Age 18 years and above
* Ferritin \<300µg/L, transferrin saturation \<25%, male 90\<Hb\<130g/L or female 90\<Hb\<120g/L
* Elective major cardiac surgery (valve replacement, CABG coronary artery bypass surgery or a combination of both)
* ASA: Grade 1-3
* Signed informed consent

Exclusion Criteria:

1. Allergy or contraindication to iron sucrose or recombinant human erythropoietin or ascorbic acid
2. Patients with a preoperative temperature \>37.5 °C or on non-prophylactic antibiotics
3. Pregnancy or breastfeeding stage
4. weight ≤ 50 kg
5. Presence of chronic renal insufficiency, urinary stones, oxalate deposits, gout
6. Chronic liver disease and/or screening alanine transferase/aspartate transferase above normal 3 times or more above the upper limit of the normal range
7. Family history of haemochromatosis, thalassaemia or transferrin saturation \> 50%
8. Known history of iron overload
9. Other known causes of anaemia (folic acid or vitamin B12 deficiency or haemoglobinopathies, etc.)
10. Emergency surgery
11. Use of iron, blood transfusion or related anaemia treatment within 12 weeks prior to surgery

Withdrawal criteria:

1. massive blood transfusion (≥ 10 red blood cells (RBC)/24h)
2. Preoperative interventions not performed according to standard
3. Cancellation of surgery

Where this trial is running

Hangzhou, Zhejiang

• The Second Affiliated Hospital of Zhejiang University Medical College — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Min Yan, Doctor — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
• Study coordinator: Min Yan

Conditions Patient Blood Management; Cardiac Surgery; Iron Deficiency Anemia