EUCTR2017-000703-24-AT进行中（未招募）1 期
Treatment of anemia with intravenous iron in patients listed fororthotopic liver transplantation - TRAILER
Medical University of Vienna; Department of Surgery; Division of Transplantation0 个研究点目标入组 60 人开始时间: 2017年10月27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
- 60
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
- •All adult patients with IDA listed for OLT at the Department of Surgery, Division of
- •Transplantation of the Medical University of Vienna will be evaluated for inclusion into
- •the study. All patients will have to provide written informed consent before inclusion
- •into the study.
- •Following criteria will be used to define IDA:
- •Hemoglobin (<12 g/dl) and ferritin (<30 µg/l)
- •In case of ferritin levels >30 µg/l one of the following criteria has to be fulfilled
- •in addition to hemoglobin levels <12 g/dl in order to define IDA:
- •o Serum iron (<50 µg/dl)
- •o Transferrin saturation (<20%)
- •o Mean corpuscular hemoglobin (<27 pg)
- •o Mean corpuscular volume (<80 fl)
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Age <18 years
- •Hemochromatosis
- •Iron utilization disorders
- •Therapy with erythropoietin-stimulating agents or intravenous iron within 4 weeks
- •prior to screening
- •Previous allergic reactions against intravenous iron formulations
- •Transfusion within 2 weeks prior to screening
- •Complete portal vein thrombosis
- •High-urgency OLT
- •Pregnancy
- •female patients breastfeeding
- •Sepsis or severe infection
- •Immunosuppressive therapy
研究者
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