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NCT Number: NCT06968936

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hangzhou, Zhejiang, 330100, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Sucrose Iron,subcutaneous recombinant human erythropoietin,intravenous vitamin C

Drug

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.

Other names: Routine perioperative management

Routine perioperative management

Procedure

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

Primary outcomes

  1. Quality of Life (EQ-5D)

    Time frame: 1 year postoperatively (±30 days)

    Assessment of health-related quality of life using the EuroQol 5-Dimension (EQ-5D) questionnaire

Secondary outcomes

  1. Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)

    Time frame: 1 year postoperatively (±30 days)

    Evaluation of sleep quality using the Pittsburgh Sleep Quality Index (PSQI)

  2. Fatigue (FACIT-Fatigue Scale)

    Time frame: 1 year postoperatively (±30 days)

    Measurement of fatigue level using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale.

  3. All-cause Complications

    Time frame: Up to 1 year postoperatively

    Occurrence of any postoperative complications from any cause during the 1-year follow-up period

  4. Hospital Readmission

    Time frame: Up to 1 year postoperatively

    Any hospital readmission for any cause within 1 year after surgery.

  5. Repeat Cardiac Surgery

    Time frame: Up to 1 year postoperatively

    Any subsequent cardiac surgery (reoperation) within 1 year after the index surgery.

  6. All-cause Mortality

    Time frame: Up to 1 year postoperatively

    Death from any cause within 1 year after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Qi Gao, Dr.

CONTACT

[email protected]

19857136919

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • First Affiliated Hospital of Chongqing Medical University
  • First Affiliated Hospital of Wenzhou Medical University
  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
  • The First Affiliated Hospital with Nanjing Medical University
  • Zhejiang Provincial People's Hospital

Registry information

Official study title

Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy in Anemic Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 13, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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