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Recruiting Not applicable

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

NCT06968936 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-03-27
Last updated
2026-04-13

Condition(s) studied

AnemiaIron DeficienciesCardiac Surgery

Investigational drug(s) / intervention(s)

Sucrose Iron,subcutaneous recombinant human erythropoietin,intravenous vitamin CRoutine perioperative management

Sucrose Iron,subcutaneous recombinant human erythropoietin,intravenous vitamin C: Patients in the experimental group will receive a combination therapy consisting of intravenous sucrose iron (200 mg), subcutaneous recombinant human erythropoietin (150 IU/kg), and intravenous vitamin C (2 g), administered once daily for three consecutive days within the week prior to surgery.

Routine perioperative management: Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participants must be at least 18 years of age. 2. Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both. 3. 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. 4. The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3. 5. Prior to participation, the patient or their legal representative must provide informed consent. Exclusion Criteria: 1. Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO. 2. Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics. 3. Individuals with a weight equal to or less than 50kg. 4. 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. 5. Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc. 6. Requirement for emergency surgical intervention. 7. 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 8. Pregnant or lactating women 9. history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeks prior to surgery 10. Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.

Primary outcome measure(s)

  • Quality of Life (EQ-5D) — 1 year postoperatively (±30 days)
    Assessment of health-related quality of life using the EuroQol 5-Dimension (EQ-5D) questionnaire

Trial sites (1)

FacilityCityRegionStatus
Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06968936 on ClinicalTrials.gov ↗ ← All trials in China