Effect of the Combined Programme on Perioperative Anaemia（CPPA）

NCT05353348 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Not applicable

Started

2023-03-15

Last updated

2025-01-10

Condition(s) studied

Patient Blood ManagementCardiac SurgeryIron Deficiency Anemia

Investigational drug(s) / intervention(s)

Iron Sucrose, recombinant human erythropoietin, ascorbic acidconventional treatment

Iron Sucrose, recombinant human erythropoietin, ascorbic acid: During the 1 week period following admission, 3 consecutive dosing regimens were administered, 200 mg of iron sucrose by intravenous infusion at 8am daily in combination with 150 IU/kg of recombinant human erythropoietin by subcutaneous injection and 2 g of ascorbic acid by intravenous infusion.

conventional treatment: Treatment in accordance with measures routinely used by the surgeon's team to treat anemia including but not limited to (clinical observation, oral iron supplementation, intravenous iron supplementation, blood transfusion, or other measures) will be documented faithfully by the study team

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Haemoglobin level on postoperative day 5 — Haemoglobin level on postoperative day 5
Haemoglobin level on postoperative day 5

Trial sites (1)

Facility	City	Region	Status
The Second Affiliated Hospital of Zhejiang University Medical College	Hangzhou	Zhejiang	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05353348 on ClinicalTrials.gov ↗ ← All trials in China