Cardiac Surgery, Iron Deficiency Anemia, Patient Blood Management
Conditions
Brief summary
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.
Interventions
DRUGIron Sucrose, recombinant human erythropoietin, ascorbic acid
During the 1 week period following admission, 3 consecutive dosing regimens were administered, 200 mg of iron sucrose by intravenous infusion at 8am daily in combination with 150 IU/kg of recombinant human erythropoietin by subcutaneous injection and 2 g of ascorbic acid by intravenous infusion.
PROCEDUREconventional treatment
Treatment in accordance with measures routinely used by the surgeon's team to treat anemia including but not limited to (clinical observation, oral iron supplementation, intravenous iron supplementation, blood transfusion, or other measures) will be documented faithfully by the study team
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Double blinding is not feasible
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemoglobin level on postoperative day 5 | Haemoglobin level on postoperative day 5 | Haemoglobin level on postoperative day 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of combination therapy on changes in perioperative haemoglobin levels | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | Pre-intervention versus post-operative haemoglobin |
| Effect of combination therapy on changes in perioperative ferritin levels | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | Pre-intervention versus post-operative ferritin |
| Effect of combination therapy on changes in perioperative reticulocyte levels | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | Magnitude of reticulocyte elevation |
| Incidence of serious adverse events (SAEs) in the perioperative period up to 6 months after surgery | Through study completion, an average of 1.5 year | Myocardial infarction、Ischemic cerebral infarction、arrhythmia、Deep vein thrombosis of the lower extremity、Pulmonary embolism, etc |
| All-cause mortality within 6 months of surgery | Through study completion, an average of 1.5 year | Incidence of mortality |
| Total length of hospital stay | Through study completion, an average of 1 year | Total length of hospital stay |
| Amount of allogeneic blood products used in the perioperative period | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | (red blood cells, plasma, platelets) |
| Post-operative intensive care unit stay | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | Length of stay in ICU after surgery |
| Infusion reactions and allergies | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | Perioperative allergic events |
| Incidence of perioperative infections | Through study completion, an average of 1 year | Non-prophylactic use of antibiotics |
| Health Care Costs | From admission until hospital discharge or postoperative day 30, whichever comes first | All medical costs during hospitalisation |
| Post-operative hospital readmission rate | Through study completion, an average of 1 year | Post-operative hospital readmission rate |
| Incidence of perioperative acute renal insufficiency | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | Postoperative creatinine more than 2 times higher than preoperative or oliguria (\<0.5ml/kg/h) within 12 hours |
Countries
China
Contacts
Primary ContactMin Yan
Outcome results
None listed