Effectiveness of Iron Sucrose Combined With rHuEPO and Ascorbic Acid in Improving Perioperative Anaemia in Patients Undergoing Major Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Haemoglobin level on postoperative day 5
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant, Investigator, Outcomes Assessor)
盲法说明
Double blinding is not feasible
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Iron treatment intervention arm
The combination therapy group will receive three treatments consisting of 200 mg/100 ml of iron sucrose IV infusion, 150 IU/Kg of erythropoietin subcutaneously and 2 mg/100 ml of vitamin C IV infusion in the week prior to surgery
干预措施: Iron Sucrose, recombinant human erythropoietin, ascorbic acid (Drug)
conventional treatment arm
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
干预措施: conventional treatment (Procedure)
结局指标
主要结局
Haemoglobin level on postoperative day 5
时间窗: Haemoglobin level on postoperative day 5
Haemoglobin level on postoperative day 5
次要结局
- Post-operative intensive care unit stay(From the start of surgery until hospital discharge or postoperative day 30, whichever comes first)
- Health Care Costs(From admission until hospital discharge or postoperative day 30, whichever comes first)
- 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)
- 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)
- Total length of hospital stay(Through study completion, an average of 1 year)
- 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)
- Incidence of perioperative acute renal insufficiency(From the start of surgery until hospital discharge or postoperative day 30, whichever comes first)
- Post-operative hospital readmission rate(Through study completion, an average of 1 year)
- 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)
- Infusion reactions and allergies(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(From the start of surgery until hospital discharge or postoperative day 30, whichever comes first)
- All-cause mortality within 6 months of surgery(Through study completion, an average of 1.5 year)
- Incidence of perioperative infections(Through study completion, an average of 1 year)