Actively Recruiting
Effectiveness of Iron Sucrose Combined With rHuEPO and Ascorbic Acid 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an innovative combination therapy to improve perioperative anemia in patients undergoing major cardiac surgery. This approach combines iron sucrose, human erythropoietin, and vitamin C to promote red blood cell production and enhance iron metabolism. Unlike previous treatments that used only intravenous iron, this strategy aims to address multiple factors affecting anemia by supporting both iron utilization and erythropoiesis more comprehensively. Participants in the combination therapy group receive three treatments during the week before surgery: 200 mg of iron sucrose by intravenous infusion, 150 IU/kg of recombinant human erythropoietin by subcutaneous injection, and 2 mg of vitamin C by intravenous infusion. The comparison group receives conventional anemia treatments routinely used by the surgical team, which may include clinical observation, oral or intravenous iron, blood transfusions, or other measures. All treatments are documented carefully by the study team. During the study, researchers monitor hemoglobin levels on postoperative day 5 as the primary outcome. They also assess the amount of blood products used, changes in hemoglobin, ferritin, and reticulocyte levels, and the incidence of complications such as acute kidney injury, infections, allergic reactions, and serious adverse events up to six months after surgery. Hospital stay duration, readmission rates, and healthcare costs are also evaluated. Participants are followed until hospital discharge or up to one year after surgery, with ongoing safety and health assessments throughout this period.
CONDITIONS
Brief 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 300bcg/L, transferrin saturation less than 25%, hemoglobin 90-130 g/L for males or 90-120 g/L for females
- Scheduled for elective major cardiac surgery such as valve replacement, coronary artery bypass surgery, 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 above 37.5 b0C or current use of non-prophylactic antibiotics
- Pregnancy or breastfeeding
- Body weight less than or equal to 50 kg
- Chronic renal insufficiency, urinary stones, oxalate deposits, or gout
- Chronic liver disease or elevated liver enzymes more than three times the normal limit
- Family history of haemochromatosis, thalassaemia, or transferrin saturation above 50%
- Known history of iron overload
- Other known causes of anemia such as folic acid or vitamin B12 deficiency or hemoglobinopathies
- Emergency surgery
- Use of iron, blood transfusion, or anemia treatment within 12 weeks before surgery
Withdrawal criteria:
- Massive blood transfusion (10 or more red blood cells within 24 hours)
- Preoperative interventions not performed according to protocol
- Surgery cancellation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants receive a combination therapy consisting of iron sucrose, recombinant human erythropoietin, and ascorbic acid administered during the 1 week period before surgery. The experimental group receives three consecutive daily dosing regimens, while the comparator group receives conventional anemia treatment as per routine care.
3 visits (in-person) during the week prior to surgery
Duration - Up to hospital discharge or postoperative day 30, whichever comes first
Participants undergo major cardiac surgery followed by immediate post-operative care in the hospital.
Daily hospital visits during stay
Duration - Up to 1 year after surgery
Participants are monitored for safety and health outcomes including adverse events, mortality, hospital readmission, and infection up to 6 months to 1 year after surgery.
Periodic follow-up visits or contacts up to 1 year
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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