Pilot Study Evaluating Efficacy and Economic Advantage of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care in Patients After Cardiac Surgery
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in hemoglobin levels
研究概览
简要总结
Primary objective: to evaluate the non-inferiority in terms of improvement of hemoglobin (Hg) levels within 30 days postoperatively between two proposed treatments.
Secondary objective: to evaluate the financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV), while demonstrating non-inferiority in the improvement of hemoglobin levels, reduction in transfusion requirements, and reduction of hospital/ICU stay length
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •ICU hospitalized patients who underwent non-emergent cardiac surgery
- •Post operative iron deficient or anemic patients (Hb< 12 for both men and women).
- •Patients following the same pre-operative protocol
- •Age >18 years
排除标准
- •Post operative day 1 Hg <9
- •Age >90 years
- •Patients with cancer or other chronic conditions that impair erythropoiesis (e.g. MDS)
- •Stage 3, 4 renal disease
- •Intraoperative transfusion of PRBC
研究组 & 干预措施
Sucrosomial® Iron
Patients will receive iron supplementation with Sucrosomial® Iron
干预措施: Sucrosomial Iron (SI) (Dietary Supplement)
Iron Sucrose injections.
Patients will receive standard of care Iron Sucrose injections.
干预措施: Sucrosomial Iron (SI) (Dietary Supplement)
结局指标
主要结局
Change in hemoglobin levels
时间窗: 30 days
Delta change of hemoglobin levels assessed at T1 in Sucrosomial Iron group to demonstrate non-inferiority compared to the Standard of Care.
Financial Cost
时间窗: 30 Days
Financial costs associated with Sucrosomial® Iron treatment compared to Iron Sucrose (IV)
次要结局
- Transfusion requirements(30 Days)
- Length of Stay(30 Days)