NCT05353348 Effect of the Combined Programme on Perioperative Anaemia（CPPA）
| NCT ID | NCT05353348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Patient Blood Management |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-03-15 |
| Primary Completion | 2025-04-01 |
Trial Parameters
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Brief Summary
We used the preoperative intervention of iron sucrose in combination with human erythropoietin and vitamin C as an innovative combination therapy. This combined treatment strategy aims to improve perioperative anaemia in patients by promoting erythropoiesis and improving iron metabolism. Compared with previous perioperative intravenous iron supplementation, this innovative combination therapy strategy takes into account multiple aspects of iron metabolism as well as the biological mechanisms of erythropoiesis, providing a more comprehensive intervention. Management of perioperative anaemia in previous studies has largely relied on single intravenous iron supplementation therapy, and although this approach has been effective in raising iron levels, its effectiveness may be limited in patients who have impaired iron utilisation or in situations where concurrent stimulation of erythropoiesis is required. The use of iron sucrose in combination with human erythropoietin and vitamin C, on the other hand, is based on an integrative therapeutic concept aimed at providing a more comprehensive response to perioperative anaemia by simultaneously promoting effective iron utilisation and erythropoiesis.
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 haemog