Actively Recruiting
Effect of the Combined Programme on Perioperative Anaemia（CPPA）
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-01-10
110
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of the Combined Programme on Perioperative Anaemia（CPPA）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and above
- Ferritin less than 300 µg/L, transferrin saturation less than 25%, male hemoglobin between 90 and 130 g/L or female hemoglobin between 90 and 120 g/L
- Scheduled for elective major cardiac surgery including valve replacement, coronary artery bypass graft, or both
- ASA physical status grade 1 to 3
- Signed informed consent
You will not qualify if you...
- Allergy or contraindication to iron sucrose, recombinant human erythropoietin, or ascorbic acid
- Preoperative temperature over 37.5 °C or current use of non-prophylactic antibiotics
- Pregnancy or breastfeeding
- Weight 50 kg or less
- Chronic kidney problems, urinary stones, oxalate deposits, or gout
- Chronic liver disease or liver enzyme levels three times above normal
- Family history of haemochromatosis, thalassaemia, or transferrin saturation over 50%
- Known history of iron overload
- Other causes of anemia such as folic acid or vitamin B12 deficiency or hemoglobin disorders
- Emergency surgery
- Use of iron, blood transfusion, or anemia treatment within 12 weeks before surgery
- Withdrawal criteria include massive blood transfusion (10 or more red blood cells in 24 hours), non-standard preoperative interventions, or surgery cancellation
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
M
Min Yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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