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: 2024年4月8日

适应症

试验速览

暂无简介。

•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

•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

发起方

Medical University of Vienna; Department of Surgery; Division of Transplantation