Innovative treatment for perioperative anaemia in cardiac surgery patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a combined treatment approach using iron sucrose, recombinant human erythropoietin, and vitamin C to address perioperative anaemia in patients undergoing elective major cardiac surgery. The study aims to enhance erythropoiesis and improve iron metabolism, offering a more comprehensive intervention compared to traditional single intravenous iron supplementation. By targeting multiple aspects of iron metabolism and erythropoiesis, this innovative strategy seeks to provide better outcomes for patients with iron deficiency anaemia. The trial includes patients with specific eligibility criteria related to their haemoglobin levels and iron status.

Why it matters

Who can join: the full rules

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

Where it's running

• The Second Affiliated Hospital of Zhejiang University Medical College
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Min Yan, Doctor — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
• Study coordinator: Min Yan
• Email: zryanmin@zju.edu.cn
• Phone: 13757118632

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Impact of Fast-Track Anesthesia on Postoperative Delirium After Cardiac Surgery

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• Sarcopenia in Patients After Cardiac Surgery

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• Preoperative functional optimization for adults undergoing major cardiac or abdominal surgery

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• Donor Breast Milk with Early Iron Supplementation in Very Preterm Infants

  In very preterm babies who mainly receive donor breast milk, this study tests whether starting iron supplementation earlier (around when feeding reaches 80 ml/kg/day) can raise ferritin and hematocrit levels by days 14 and 28.

  Recruiting AdventHealth · Orlando, Florida · NCT07816601

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.