Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy in Anemic Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Quality of Life (EQ-5D)
研究概览
简要总结
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.
详细描述
- Hypothesis:The combined protocol of preoperative sucrose iron, human erythropoietin, and vitamin C will demonstrate superiority in reducing perioperative allogeneic red blood cell (RBC) transfusion volume compared to standard care in patients with iron deficiency anemia undergoing major cardiac surgery with cardiopulmonary bypass.
- Interventions 2.1.Experimental group: 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. All perioperative transfusion decisions will follow standardized restrictive transfusion thresholds.
2.2.Control group: Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices. 3. Primary endpoint: Total volume of allogeneic RBC transfusion (units) from surgery initiation to postoperative day 5. 4. Stratification in randomization: Stratification factors include types of surgery, preoperative baseline hemoglobin level. 5. Outcome assessors will be blinded to group allocation to reduce assessment bias. 6. Follow-up time points include: baseline upon hospital admission, the morning of surgery, postoperative day 1, postoperative day 5, at discharge, 30 ± 7 days after surgery, and 90 ± 7 days after surgery. 7. When the patient's hemoglobin concentration falls below the threshold of 70 g/L during surgery or ICU monitoring, or below 70-80 g/L in the general ward, and/or when signs of anemia or hemodynamic instability are present-including shock, severe arrhythmias, respiratory distress, heart rate >120 beats/min, systolic blood pressure (SBP) <80 mmHg, mean arterial pressure (MAP) <55-60 mmHg, or a reduction in SBP or MAP exceeding 25% from baseline-these findings may indicate significant hypovolemia and warrant consideration of transfusion intervention.
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
- Single (Outcomes Assessor)
盲法说明
Blinding was maintained for outcome assessors, extracorporeal circulation staff, and all investigators not directly involved in the treatment process.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be at least 18 years of age.
- •Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both.
- •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.
- •The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-
- •Prior to participation, the patient or their legal representative must provide informed consent.
排除标准
- •Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO.
- •Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics.
- •Individuals with a weight equal to or less than 50kg.
- •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.
- •Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc.
- •Requirement for emergency surgical intervention.
- •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
- •Pregnant or lactating women
- •history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeks prior to surgery
- •Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.
研究组 & 干预措施
Combined Iron Supplementation Group
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. All perioperative transfusion decisions will follow standardized restrictive transfusion thresholds
干预措施: Sucrose Iron，subcutaneous recombinant human erythropoietin，intravenous vitamin C (Drug)
Conventional treatment group
Routine perioperative management based on clinical judgment, including observation, monitoring, and standard nursing practices
干预措施: Routine perioperative management (Procedure)
结局指标
主要结局
Quality of Life (EQ-5D)
时间窗: 1 year postoperatively (±30 days)
Assessment of health-related quality of life using the EuroQol 5-Dimension (EQ-5D) questionnaire
The volume of allogeneic red blood cell transfusions during the perioperative period.
时间窗: From the initiation of the surgical procedure until five days post-surgery.
The volume of allogeneic red blood cell transfusions during the perioperative period.
次要结局
- Length of stay in the intensive care unit (ICU)(Within 90± 7 days after surgery)
- Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)(1 year postoperatively (±30 days))
- Fatigue (FACIT-Fatigue Scale)(1 year postoperatively (±30 days))
- All-cause Complications(Up to 1 year postoperatively)
- Hospital Readmission(Up to 1 year postoperatively)
- Repeat Cardiac Surgery(Up to 1 year postoperatively)
- All-cause Mortality(Up to 1 year postoperatively)
- Percentage of patients with any RBC transfusions(From the initiation of the surgical procedure until discharge. Perioperative)
- Combined allogeneic transfusions (RBC, FFP( fresh frozen plasma), platelets)(From the initiation of the surgical procedure until discharge. Perioperative)
- Perioperative Hb concentrations(Follow-up time points include: baseline upon hospital admission, the morning of surgery, postoperative day 1, postoperative day 5, at discharge, 30 ± 7 days after surgery, and 90 ± 7 days after surgery.)
- The alterations in ferritin levels and TSAT during the perioperative period.(6.Follow-up time points include: baseline upon hospital admission, the morning of surgery, postoperative day 1, postoperative day 5, at discharge, 30 ± 7 days after surgery, and 90 ± 7 days after surgery.)
- The alterations in reticulocyte levels during the perioperative period.(6.Follow-up time points include: baseline upon hospital admission, the morning of surgery, postoperative day 1, postoperative day 5, at discharge, 30 ± 7 days after surgery, and 90 ± 7 days after surgery.)
- The score measuring the quality of life after surgery.(From the point of randomisation until 90± 7 days following the surgical procedure.)
- Acute kidney failure(From the initiation of the surgical procedure until 7 days post-surgery.)
- Major Adverse Cardiac and Cerebrovascular Events (MACCE)(From the point of randomisation until 90± 7 days following the surgical procedure.)
- New atrial fibrillation(From the point of randomisation until 90± 7 days following the surgical procedure.)
- Infections(From the initiation of the surgical procedure until discharge. Perioperative)
- Thrombotic and thromboembolic complications(From the initiation of the surgical procedure until discharge. Perioperative)
- 30 day and 90-day mortality(From the initiation of the surgical procedure until discharge. Perioperative)
- Costs (for blood products and pharmaceutical products related to transfusion and anemia management)(From the initiation of the surgical procedure until discharge. Perioperative)
- All serious adverse events(From the initiation of the surgical procedure until discharge. Perioperative)
- Length of stay (LOS) in the hospital(Within 90± 7 days after surgery)