Actively Recruiting
The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-04-16
400
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
F
First Affiliated Hospital of Wenzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if a combined iron supplementation regimen can reduce the need for blood transfusions in adults with iron-deficiency anemia undergoing major elective cardiac surgery. The trial will also look at whether this regimen is safe and well tolerated. The main questions it aims to answer are: Does the combined regimen lower the amount of allogeneic red blood cell transfusion needed during and after surgery? Are there any side effects or safety concerns associated with the regimen? Researchers will compare the combined iron supplementation (sucrose iron, erythropoietin, and vitamin C) to standard care to see if it helps reduce blood transfusions. Participants will: Receive either the combined regimen or standard care before surgery Undergo major elective cardiac surgery under general anesthesia Be monitored for blood transfusion needs and recovery up to 90 days after surgery
CONDITIONS
Official Title
The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for major cardiac surgery such as coronary artery bypass grafting, valve surgery, or both
- Iron deficiency anemia defined by ferritin below 100 bcg/L or ferritin below 300 bcg/L with transferrin saturation below 25%, and hemoglobin 90-130 g/L for men or 90-120 g/L for women
- American Society of Anesthesiologists (ASA) classification grade 1 to 3
- Provided informed consent prior to participation
You will not qualify if you...
- Contraindications to iron sucrose, vitamin C, or recombinant human erythropoietin
- Fever over 37.5 b0C or use of non-prophylactic antibiotics
- Weight 50 kg or less
- Family history of haemochromatosis or thalassaemia, transferrin saturation above 50%, or history of iron overload
- Other blood disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, granulocytic anaemia, G6PD deficiency
- Need for emergency surgery
- Severe liver or kidney problems (ALT or AST over 3 times normal, creatinine over 1.5 times normal)
- Pregnant or breastfeeding women
- Blood transfusion or intravenous iron or vitamin C use within 12 weeks before surgery
- Acute blood loss or gastrointestinal bleeding before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here