Effect of Perioperative Iron Isomaltoside 1000 Administration on Transfusion Requirements in Patients Undergoing Complex Valvular Heart Surgery: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- the proportion of patients who need blood transfusion
研究概览
简要总结
In complex cardiac surgery with prolonged cardiopulmonary bypass, allogeneic blood products transfusions are often necessary to control intraoperative and postoperative bleeding. Furthermore, approximately 50% of all patients undergoing cardiac surgery are anemic before surgery, and patients with normal hemoglobin level may become anemic during and/or after surgery. Perioperative transfusion carries risks far beyond transmission of infection and has been demonstrated to be associated with adverse outcomes related to postoperative pulmonary complications, decreased renal function and increased mortality. Thus, the important of blood conservation stratigies to minimize transfusion is being increasingly emphasized. In recent trial by Johansson and colleagues, they concluded that the perioperative administration of intravenous iron isomaltoside 1000 increased the hemoglobin level and prevented anemia 4 weeks after cardiac surgery. Therefore, perioperative iron isomaltoside 1000 administration among the patients undergoing complex valvular heart surgery could reduce not only the perioperative allogeneic transfusion but also the incidence of postoperative adverse events. The aim of this study is to examine the effect of perioperative iron isomaltoside 1000 administration on transfusion requirements in patients undergoing complex valvular heart surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients undergoing redo cardiac surgery or complex valvular heart surgery with cardiopulmonary bypass
- •tha age ≥19 yrs old.
- •the patients who are willing to provide written informed consent
排除标准
- •having preoperative anemia (Hb <9 g/dl for women, Hb <10 g/dl for men)
- •preoperative erythropoietin treatment within four weeks before surgery
- •redo cardiac operation due to preoperative paravalvular leakage
- •known hypersensitivity to any excipients in the investigational drug products
- •aplastic anemia
- •the patients who stay more than 48 hours in the intensive care unit preoperatively due to heart failure or other major complication
研究组 & 干预措施
IV iron
The patients will receive iron isomaltoside 1000 (Monofer®) as an i.v. infusion of 1000 mg (diluted with normal saline, 10 mg/ml) twice; 3 days before surgery and 3 days after surgery. They will receive iron isomaltoside 1000 (Monofer®) 1000 mg over 15 min.
干预措施: iron isomaltoside 1000 (Monofer®) (Drug)
Control
The patients will receive normal saline 100 ml as an i.v. infusion twice; 3 days before surgery and 3 days after surgery. They will receive normal saline 100 ml over 15 min.
干预措施: normal saline 100 ml (Drug)
结局指标
主要结局
the proportion of patients who need blood transfusion
时间窗: patients will be followed for the duration of hospital stay, an expected average of 10 days after surgery
Investigator will assess the number of patients in each group who will need blood transfusion during hospital stays, and evaluate the effect of iron isomaltoside 1000 (Monofer®) on perioperative blood transfusion.
次要结局
- the proportion of patients who will experience postoperative adverse events(within the first 20 days after surgery. (plus or minus 3 days))
- the plasma hepcidin concentrations of patients(before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery)
- the plasma EPO (erythropoietin) concentrations of patients(before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery)