EUCTR2013-004979-13-DK进行中（未招募）1 期
Treatment of Preoperative Anaemia in Patients with Urogenital Cancer: A Randomised Double-Blind Placebo-Controlled Study of Intravenous Iron Isomaltide 1000 Monofer© versus Saline
Rigshospitalet, 20320 个研究点开始时间: 2014年1月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •Anaemia: males Hb< 13g/dL (8.0 mmol/L), females Hb< 11.3 g/dL (7.0 mmol/L)
- •Age > 18 years
- •Iron deficiency anaemia and anaemia of chronic disease: P-Ferritin<100ug/L eller P-Ferritin 100-800ug/L og TSAT<20 %
- •Able to give informed consent vulantary
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •Anaemia< Hb= 8 g/dL (5.0mmol/L) or anaemia related to other causes than iron deficiency anaemia and anaemia of chronic disease
- •Known hypersensibility to intravenous iron
- •Acute or chronic infection (assessed by clinical judgement supplied with WBC and CRP)
- •Decompensated liver cirrhosis or hepatitis (ALAT>3x normal)
- •Rheumatoid arthritis with symptoms or signs of acute inflammation (assessed by clinical judgement and CRP)
- •Haemosiderosis or haemochromatosis
- •RBC transfusion two weeks prior inclusion
- •Intravenous iron or ESA four weeks prior inclusion
- •Uraemia with creatinine>250 umol/L or haemodialysis
- •Participating in another clinical study
研究者
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