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

ConditionsAnemiaIron DeficienciesCardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Routine perioperative management

    Procedure/Surgery

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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Combined Iron Supplementation GroupExperimental treatment 1 intervention
Group B: Conventional treatment groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Life (EQ-5D)

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

Time frame
1 year postoperatively (±30 days)

Secondary outcomes

1

Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)

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

Time frame
1 year postoperatively (±30 days)
2

Fatigue (FACIT-Fatigue Scale)

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

Time frame
1 year postoperatively (±30 days)
3

All-cause Complications

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

Time frame
Up to 1 year postoperatively
4

Hospital Readmission

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

Time frame
Up to 1 year postoperatively

Other outcomes

Sponsors and contacts

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Collaborator

The First Affiliated Hospital with Nanjing Medical University

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Zhejiang Provincial People's Hospital

Collaborator

Source ClinicalTrials.gov
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