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Effect of the Combined Programme on Perioperative Anaemia（CPPA）

RecruitingNAAges 18 Years - anyAllSecond Affiliated Hospital, Zhejiang University, …
NCT05353348 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 erythropoiesi

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📋 Eligibility rules (as published)
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
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What it tests

  • Iron Sucrose, recombinant human erythropoietin, ascorbic acid
  • conventional treatment
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Where

1 site
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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