Cardiac Surgery Clinical Trial
Official title:
Effectiveness of Iron Sucrose Combined With rHuEPO and Ascorbic Acid in Improving Perioperative Anaemia in Patients Undergoing Major Cardiac Surgery
We used the preoperative intervention of iron sucrose in combination with human erythropoietin and vitamin C as an innovative combination therapy. This combined treatment strategy aims to improve perioperative anaemia in patients by promoting erythropoiesis and improving iron metabolism. Compared with previous perioperative intravenous iron supplementation, this innovative combination therapy strategy takes into account multiple aspects of iron metabolism as well as the biological mechanisms of erythropoiesis, providing a more comprehensive intervention. Management of perioperative anaemia in previous studies has largely relied on single intravenous iron supplementation therapy, and although this approach has been effective in raising iron levels, its effectiveness may be limited in patients who have impaired iron utilisation or in situations where concurrent stimulation of erythropoiesis is required. The use of iron sucrose in combination with human erythropoietin and vitamin C, on the other hand, is based on an integrative therapeutic concept aimed at providing a more comprehensive response to perioperative anaemia by simultaneously promoting effective iron utilisation and erythropoiesis.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years and above - Ferritin <300µg/L, transferrin saturation <25%, male 90<Hb<130g/L or female 90<Hb<120g/L - Elective major cardiac surgery (valve replacement, CABG coronary artery bypass surgery or a combination of both) - ASA: Grade 1-3 - Signed informed consent Exclusion Criteria: 1. Allergy or contraindication to iron sucrose or recombinant human erythropoietin or ascorbic acid 2. Patients with a preoperative temperature >37.5 °C or on non-prophylactic antibiotics 3. Pregnancy or breastfeeding stage 4. weight = 50 kg 5. Presence of chronic renal insufficiency, urinary stones, oxalate deposits, gout 6. Chronic liver disease and/or screening alanine transferase/aspartate transferase above normal 3 times or more above the upper limit of the normal range 7. Family history of haemochromatosis, thalassaemia or transferrin saturation > 50% 8. Known history of iron overload 9. Other known causes of anaemia (folic acid or vitamin B12 deficiency or haemoglobinopathies, etc.) 10. Emergency surgery 11. Use of iron, blood transfusion or related anaemia treatment within 12 weeks prior to surgery Withdrawal criteria: 1. massive blood transfusion (= 10 red blood cells (RBC)/24h) 2. Preoperative interventions not performed according to standard 3. Cancellation of surgery |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital of Zhejiang University Medical College | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Haemoglobin level on postoperative day 5 | Haemoglobin level on postoperative day 5 | Haemoglobin level on postoperative day 5 | |
Secondary | Amount of allogeneic blood products used in the perioperative period | (red blood cells, plasma, platelets) | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | |
Secondary | Effect of combination therapy on changes in perioperative haemoglobin levels | Pre-intervention versus post-operative haemoglobin | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | |
Secondary | Effect of combination therapy on changes in perioperative ferritin levels | Pre-intervention versus post-operative ferritin | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | |
Secondary | Effect of combination therapy on changes in perioperative reticulocyte levels | Magnitude of reticulocyte elevation | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | |
Secondary | Incidence of perioperative acute renal insufficiency | Postoperative creatinine more than 2 times higher than preoperative or oliguria (<0.5ml/kg/h) within 12 hours | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | |
Secondary | Post-operative intensive care unit stay | Length of stay in ICU after surgery | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | |
Secondary | Infusion reactions and allergies | Perioperative allergic events | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | |
Secondary | Incidence of serious adverse events (SAEs) in the perioperative period up to 6 months after surgery | Myocardial infarction?Ischemic cerebral infarction?arrhythmia?Deep vein thrombosis of the lower extremity?Pulmonary embolism, etc | Through study completion, an average of 1.5 year | |
Secondary | All-cause mortality within 6 months of surgery | Incidence of mortality | Through study completion, an average of 1.5 year | |
Secondary | Total length of hospital stay | Total length of hospital stay | Through study completion, an average of 1 year | |
Secondary | Incidence of perioperative infections | Non-prophylactic use of antibiotics | Through study completion, an average of 1 year | |
Secondary | Health Care Costs | All medical costs during hospitalisation | From admission until hospital discharge or postoperative day 30, whichever comes first | |
Secondary | Post-operative hospital readmission rate | Post-operative hospital readmission rate | Through study completion, an average of 1 year |
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