Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hemoglobin at OLT
研究概览
简要总结
The aim of this study is to investigate whether therapy with intravenous iron carboxymaltose in patients with iron deficiency anemia (IDA) listed for orthotopic liver transplantation (OLT) increases hemoglobin concentrations and reduces intraoperative transfusion of packed red blood cells (PRBCs). The investigators hypothesize that therapy with intravenous iron will increase hemoglobin concentrations and reduce intraoperative transfusion of PRBCs in patients with IDA listed for OLT.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •patients listed for OLT with positive screening for IDA
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
- •Sepsis or severe infection
- •Immunosuppressive therapy
研究组 & 干预措施
Group A
IV administration of iron-III-carboxymaltose according to iron deficit every 4 weeks.
干预措施: Iron Carboxymaltose (Drug)
Group B
IV administration of 1000ml 0.9% NaCl every 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Hemoglobin at OLT
时间窗: 6 months
Change in hemoglobin concentrations from baseline until before induction of anesthesia for OLT
次要结局
- Transfusion requirement(6 months)
- Hemoglobin after 4 weeks(4 weeks)
研究者
Georg Gyoeri
Head of Liver Transplantation Outpatient Clinic
Medical University of Vienna