Status:
RECRUITING
Perioperative Blood Conservation: Role of Combined Iron Supplementation Protocols in Reducing Allogeneic Transfusion
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
First Affiliated Hospital of Chongqing Medical University
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Conditions:
Anemia
Iron Deficiencies
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 cardia...
Detailed Description
1. Hypothesis:The combined protocol of preoperative sucrose iron, human erythropoietin, and vitamin C will demonstrate superiority in reducing perioperative allogeneic red blood cell (RBC) transfusion...
Eligibility Criteria
Inclusion
- Participants must be at least 18 years of age.
- Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both.
- Iron deficiency anemia is defined as having a ferritin level below 100 μg/L or a ferritin level below 300 μg/L accompanied by a transferrin saturation below 25%. Additionally, hemoglobin levels should range between 90 and 130 g/L for men or between 90 and 120 g/L for women.
- The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3.
- Prior to participation, the patient or their legal representative must provide informed consent.
Exclusion
- Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO.
- Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics.
- Individuals with a weight equal to or less than 50kg.
- Individuals with a family history of haemochromatosis or thalassaemia, or those with a transferrin saturation level exceeding 50% or a documented history of iron overload.
- Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc.
- Requirement for emergency surgical intervention.
- Severe hepatic or renal impairment, ALT \>3 times the upper limit of normal value or AST \>3 times the upper limit of normal value, creatinine \>1.5 times the upper limit of normal value
- Pregnant or lactating women
- history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeks prior to surgery
- Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06968936
Start Date
May 15 2025
End Date
September 30 2027
Last Update
May 13 2025
Active Locations (1)
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1
Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 330100