Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06968936

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-04-13

400

Participants Needed

1

Research Sites

170 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead Sponsor

F

First Affiliated Hospital of Chongqing Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be at least 18 years of age.
  • Scheduled for major cardiac surgery such as coronary artery bypass grafting, valve surgery, or both.
  • Diagnosed with iron deficiency anemia defined by ferritin levels below 100 bcg/L or ferritin below 300 bcg/L with transferrin saturation under 25%, and hemoglobin levels between 90-130 g/L for men or 90-120 g/L for women.
  • American Society of Anesthesiologists (ASA) classification Grade 1-3.
  • Informed consent provided by patient or legal representative prior to participation.
Not Eligible

You will not qualify if you...

  • Contraindications to iron sucrose, ascorbic acid, or recombinant human erythropoietin.
  • Fever over 37.5 C or taking non-prophylactic antibiotics.
  • Body weight 50 kg or less.
  • Family history of haemochromatosis or thalassaemia, transferrin saturation over 50%, or history of iron overload.
  • Other blood disorders such as folic acid or vitamin B12 deficiency, haemolytic anemia, haemoglobinopathies, iron granulocytic anemia, G6PD deficiency.
  • Need for emergency surgery.
  • Severe liver or kidney problems (ALT or AST more than 3 times normal, creatinine more than 1.5 times normal).
  • Pregnant or breastfeeding women.
  • Blood transfusion, intravenous iron, or vitamin C use within 12 weeks before surgery.
  • Acute blood loss or gastrointestinal bleeding before surgery.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 330100

Actively Recruiting

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Research Team

Q

Qi Gao, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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