Effect of the Combined Programme on Perioperative Anaemia（CPPA）

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Apr 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach to help patients with low red blood cell levels, also known as perioperative anemia, who are preparing for major heart surgeries like valve replacement or bypass surgery. The treatment combines iron sucrose, human erythropoietin (a hormone that helps produce red blood cells), and vitamin C to improve how the body uses iron and promotes the production of red blood cells. This approach aims to be more effective than traditional methods that only provide iron, especially for patients who may have trouble using iron properly.

To participate in the trial, individuals must be 18 years or older, have specific low iron levels, and be scheduled for elective heart surgery. They cannot have certain health conditions, allergies, or recent treatments that could interfere with the study. Participants will receive the combined treatment before their surgery and will be monitored throughout the process. This research is important as it seeks to provide better care for patients facing surgery and help prevent complications related to anemia.

Gender

ALL

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