Anemia, Cardiac Surgery, Iron Deficiencies
Conditions
Brief 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.
Interventions
DRUGSucrose 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.
PROCEDURERoutine perioperative management
Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital of Chongqing Medical University
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
The First Affiliated Hospital with Nanjing Medical University
First Affiliated Hospital of Wenzhou Medical University
Zhejiang Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinding was maintained for outcome assessors, extracorporeal circulation staff, and all investigators not directly involved in the treatment process.
Intervention model description
Central stratified block group randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality (Pittsburgh Sleep Quality Index, PSQI) | 1 year postoperatively (±30 days) | Evaluation of sleep quality using the Pittsburgh Sleep Quality Index (PSQI) |
| Fatigue (FACIT-Fatigue Scale) | 1 year postoperatively (±30 days) | Measurement of fatigue level using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale. |
| All-cause Complications | Up to 1 year postoperatively | Occurrence of any postoperative complications from any cause during the 1-year follow-up period |
| Hospital Readmission | Up to 1 year postoperatively | Any hospital readmission for any cause within 1 year after surgery. |
| Repeat Cardiac Surgery | Up to 1 year postoperatively | Any subsequent cardiac surgery (reoperation) within 1 year after the index surgery. |
| All-cause Mortality | Up to 1 year postoperatively | Death from any cause within 1 year after surgery. |
Countries
China
Contacts
CONTACTQi Gao, Dr.
Outcome results
None listed