CardioSideral Heart Surgery: Randomized Study on Sucrosomial Iron Supplementation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,023
- 试验地点
- 1
- 主要终点
- Preoperative Hemoglobin Level
研究概览
简要总结
This randomized, single blind (Outcomes Assessor), non-profit study is aimed at verifying whether routine preoperative supplementation with Sucrosomial® Iron in patients scheduled for cardiac surgery may increase baseline haemoglobin, constrain the haemoglobin decrease between postoperative day 2 and 3 (haemoglobin drift), and reduce the postoperative transfusion requirements, in order to identify a new strategy for pre-hospitalization optimization and post-operative recovery.
详细描述
This randomized, single blind (Outcomes Assessor), non-profit study is aimed at verifying whether routine preoperative supplementation with Sucrosomial® Iron in patients scheduled for cardiac surgery may increase baseline haemoglobin, constrain the haemoglobin decrease between postoperative day 2 and 3 (haemoglobin drift), and reduce the postoperative transfusion requirements, in order to identify a new strategy for pre-hospitalization optimization and post-operative recovery.
Secondary Objectives are
- Changes in blood chemistry and biochemical tests between pre- and post-intervention
- Evaluation of tolerability and compliance of supplementation with Sucrosomal Iron
- Reduction in the number of transfusions and blood bags used
- Evaluation of cost-effectiveness
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
Single blinded
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective Heart Surgery -
排除标准
- •Emergent or Urgent Indication
研究组 & 干预措施
CardioSIDERAL
Adminsitration of 2 pills per day of CArdiosideral from 30 days before operation to time of operation
干预措施: Sucrosomial Iron (Drug)
结局指标
主要结局
Preoperative Hemoglobin Level
时间窗: 30 days from enrollment
Preoperative Hemoglobin Level
次要结局
- Compliance to drug(30 days from enerollemnt)
- Cost-effectiveness in terms of cost of drug vs saved blood units(30 days after operation)
- Hemoglobin Level 24 hours after operation(24 hours after index operation)
- Hemoglobin Level 48 hours after operation(48 hours after index operation)
研究者
Luca Weltert
Clinical Professor, Principal Investigator
Cardiochirurgia E.H.