Actively Recruiting
Effectiveness of Iron Sucrose Combined With Recombinant Human Erythropoietin and Vitamin C in Improving Perioperative Anaemia in Patients Undergoing Major Cardiac Surgery
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
This trial investigates an innovative combination therapy using iron sucrose, recombinant human erythropoietin, and vitamin C to improve perioperative anemia in patients undergoing major cardiac surgery. The approach aims to enhance erythropoiesis and iron metabolism more comprehensively than previous single intravenous iron supplementation methods. It focuses on managing anemia in patients with impaired iron utilization or those needing stimulation of red blood cell production during the perioperative period. Participants receive a combined treatment over one week after hospital admission. This includes daily intravenous infusions of 200 mg iron sucrose and 2 g of ascorbic acid, along with a subcutaneous injection of 150 IU/kg recombinant human erythropoietin. The study also includes a comparison with conventional treatments used by surgeons, such as clinical observation, oral or intravenous iron supplementation, blood transfusion, or other routine anemia management methods. Throughout the study, researchers monitor hemoglobin levels, especially focusing on the level on postoperative day 5 as the primary outcome. Participants undergo regular assessments to evaluate anemia status and treatment effects. The study documents all treatments faithfully and tracks safety and efficacy outcomes during the perioperative period in patients undergoing elective major cardiac surgery.
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
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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