Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy

Recruiting now · Not applicable

Conditions studied: Anemia, Iron Deficiencies, Cardiac Surgery

In brief

This is a sub-study of the Preoperative Combined Iron Therapy trail in which some participants will be additionally randomized to combined iron supplementation or standarded treatment control to evaluate the impact on long-term outcomes.

Key facts

Study ID

NCT06968936

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

400

Starts

2026-03-27

Expected to finish

2029-06-30

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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