Effect of the Combined Programme on Perioperative Anaemia（CPPA）

Last updated: January 8, 2025
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Surgery

Anemia

Treatment

conventional treatment

saline

Iron Sucrose, recombinant human erythropoietin, ascorbic acid

Clinical Study ID

NCT05353348
2022-0156
  • Ages > 18
  • All Genders

Study 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

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 bypasssurgery or a combination of both)

  • ASA: Grade 1-3

  • Signed informed consent

Exclusion

Exclusion Criteria:

  1. Allergy or contraindication to iron sucrose or recombinant human erythropoietin orascorbic 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 transferaseabove 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 orhaemoglobinopathies, etc.)

  10. Emergency surgery

  11. Use of iron, blood transfusion or related anaemia treatment within 12 weeks prior tosurgery

Withdrawal criteria:

  1. massive blood transfusion (≥ 10 red blood cells (RBC)/24h)

  2. Preoperative interventions not performed according to standard

  3. Cancellation of surgery

Study Design

Total Participants: 110
Treatment Group(s): 3
Primary Treatment: conventional treatment
Phase:
Study Start date:
March 15, 2023
Estimated Completion Date:
April 01, 2025

Connect with a study center

  • The Second Affiliated Hospital of Zhejiang University Medical College

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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