EUCTR2017-001823-26-IT进行中（未招募）1 期
Efficacy and Safety of Intravenous Ferric Carboxymaltose in PatientsUndergoing Cardiac Surgery A Randomized Controlled Study - IDECAS RCT 3.0
IVERSITÀ CAMPUS BIO-MEDICO DI ROMA0 个研究点目标入组 50 人开始时间: 2021年6月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •LVEF = 40%
- •Ferritin < 100 ng/mL
- •or between 100-300
- •ng/mL with TSAT <
- •Hb < 15 g/dl
- •age >18 years of age
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Subject with sensitivity to intravenous iron
- •2. History of acquired iron overload
- •3. Known active bacterial infection
- •4. Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or
- •aspartate transaminase above three times the upper
- •limit of the normal rang
- •6. Hypersensitivity to any of its excipients listed in IMP (section 6.1)
- •5. Clinical evidence of current malignancy
- •6. Currently receiving systemic chemotherapy and/or radiotherapy
- •7. Renal dialysis
研究者
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