POSTOPERATIVE SUCROSOMIAL IRON IN HEART SURGERY: DOSE FINDING PROSPECTIVE STUDY (SideralDose)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Hemoglobin
研究概览
简要总结
Randomization to different doses of Sucrosomial Iron for one moth after discharge to rehab after heart surgery to assess if more iron grants a faster recovery or not
详细描述
Evaluation of the efficacy of short-term sucrosomial iron treatment in patients undergoing cardiac surgery and subsequently transferred to rehabilitation, measured in terms of increase in hemoglobin values and restoration of martial blood parameters, administering doses of 30mg, 60mg and 120mg respectively, after randomization of patients.
Numerical congruity analysis, power sampling, biometric characteristics of internal compatibility between cohorts and outcome analysis with comparison for continuous homoscedastic case-control variables
Drafting of formal statistical analysis, drafting of information synopsis, writing, validation, forwarding to scientific journal and correction until obtaining, where possible, publications of the manuscript relating to the research.
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
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hb<11; Having had Heart Surgery, Being Discharged to Rehab
排除标准
- •Hb>11.1, hematological primary disesases
研究组 & 干预措施
30mg
1 cp (30mg) per day of Sucrosomial Iron
干预措施: Sucrosomial Iron (Drug)
60mg
2 cp (60mg) per day of Sucrosomial Iron
干预措施: Sucrosomial Iron (Drug)
120mg
4 cp (120mg) per day of Sucrosomial Iron
干预措施: Sucrosomial Iron (Drug)
结局指标
主要结局
Hemoglobin
时间窗: 30 days
Hemoglobin level at 30 day of treatment
次要结局
- Martial Metabolism(30 days)