EUCTR2014-002827-87-NL进行中（未招募）不适用
Multicenter randomized controlled trial comparing Ferric(III)carboxymaltose infusion with oral iron suppletion in the treatment of preoperative anemia in colorectal cancer patients - FIT trial
Academic Medical Center0 个研究点开始时间: 2014年10月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •-Colorectal carcinoma
- •-Laparoscopic or open segment resection or a low anterior resection
- •-Iron deficiency anemia: Hb <7,5mmol/l (12 g/dl) for women and Hb <8 mmol/l (13 g/dl) for men en TSAT<20%
- •-Age 18 years or older
- •-Written informed consent for study participation
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 128
排除标准
- •-Palliative surgery / metastasized disease
- •-Received blood transfusion within one month before screening
- •-Serum ferritin = 800 µg/L
- •-Pregnancy
- •-Preoperative chemoradiation (Short 5x5gy = no exclusion)
- •-Contraindication for the use of Ferric(III)carboxymaltose or ferrofumarate
- •-ASA classification > 3
- •-Use of erythropoietin stimulating agents within three months before screening
- •-Chronic kidney disease (GFR < 30ml/min/m)
- •-Myelodysplastic syndrome
- •-Severe anemia with indication for blood transfusion
- •-Hereditary Heamochromatosis
- •-Thalassemia
- •-Hemolytic anemia/ chronic hemolysis
研究者
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