Effect of Perioperative Iron Treatment on Allogenic Blood Transfusion

Study Overview
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Brief Summary
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This study was designed to investigate the effect of iron sucrose combined with rHuEPO and ascorbic acid on perioperative allogeneic red blood cell transfusion in patients undergoing elective major cardiac surgery by evaluating outcome indicators such as perioperative allogeneic red blood cell transfusion rates and changes in perioperative haemoglobin levels.

Detailed Description
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Perioperative anaemia is one of the most common comorbidities in patients undergoing surgery, with a prevalence of up to 30% in patients undergoing cardiac surgery. Perioperative anaemia can lead to ischaemia and hypoxia in vital organs, increased postoperative complications and even increased mortality; in addition to an increased rate of allogeneic blood product transfusions and significantly longer ICU and hospital stays. Correcting perioperative anaemia and reducing complications are of great importance to improve the immediate and long-term prognosis of patients undergoing major cardiac surgery.

Official Title
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Iron Sucrose Combined With rHuEPO and Ascorbic Acid on Perioperative Allogeneic Red Blood Cell Infusion in Patients Undergoing Elective Major Cardiac Surgery

Conditions
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Patient Blood Management, Cardiac Surgery, Iron Deficiency Anemia

Intervention / Treatment
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* Drug: Iron Sucrose, recombinant human erythropoietin, ascorbic acid
* Drug: Iron sucrose


Participation Criteria
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Eligibility Criteria
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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: Allergy or contraindication to iron sucrose or recombinant human erythropoietin or ascorbic acid Patients with a preoperative temperature >37.5 °C or on non-prophylactic antibiotics Pregnancy or breastfeeding stage weight ≤ 50 kg Presence of chronic renal insufficiency, urinary stones, oxalate deposits, gout Chronic liver disease and/or screening alanine transferase/aspartate transferase above normal 3 times or more above the upper limit of the normal range Family history of haemochromatosis, thalassaemia or transferrin saturation > 50% Known history of iron overload Other known causes of anaemia (folic acid or vitamin B12 deficiency or haemoglobinopathies, etc.) Emergency surgery Use of iron, blood transfusion or related anaemia treatment within 12 weeks prior to surgery Withdrawal criteria: massive blood transfusion (≥ 10 red blood cells (RBC)/24h) Preoperative interventions not performed according to standard Cancellation of surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron treatment intervention arm<br> | Drug: Iron Sucrose, recombinant human erythropoietin, ascorbic acid<br>* 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.<br>|
| Active Comparator: control arm<br> | Drug: Iron sucrose<br>* Within 1 week of admission, 3 consecutive combination regimens of 200mg of iron sucrose and saline combined with subcutaneous saline infusions at 8am daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative allogeneic red blood cell infusion rate | Perioperative allogeneic red blood cell infusion rate | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Infusion reactions and allergies | Perioperative allergic events | From the start of surgery until hospital discharge or postoperative day 30, whichever comes first | 
| 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 | 
| All-cause mortality within 6 months of surgery | Incidence of mortality | Through study completion, an average of 1.5 year | 
| Total length of hospital stay | Total length of hospital stay | Through study completion, an average of 1 year | 
| Incidence of perioperative infections | Non-prophylactic use of antibiotics | Through study completion, an average of 1 year | 
| Health Care Costs | All medical costs during hospitalisation | From admission until hospital discharge or postoperative day 30, whichever comes first | 
| Post-operative hospital readmission rate | Post-operative hospital readmission rate | Through study completion, an average of 1 year |