NL-OMON50394已完成4 期
Multicenter randomized controlled trial comparing Ferric(III)carboxymaltose infusion with oral iron suppletion in the treatment of perioperative anemia in patients with a colorectal carcinoma. - FIT-trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Chirurgie
- 入组人数
- 198
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with:
- •- Colorectal carcinoma
- •- Laparoscopic or open segment resection or a low anterior resection
- •- Iron deficiency anemia: Hb <7,5 for women and Hb <-8 mmol/ L for men en
- •- Age 18 years or older
- •-Written informed consent for study participation
排除标准
- •- Palliative surgery / metastasized disease
- •- Received blood transfusion within one month before screening
- •- Serum ferritine * 800 µg/L
- •- Pregnancy
- •- Preoperative chemoradiation (Short 5x5gy = no exclusion)
- •- Contraindication for the use of Ferinject or ferrofumarate
- •- ASA classification > 3
- •- Use of erythropoietin stimulating agents within three months before screening
- •- Chronic kidney disease (GFR < 30ml/min/m)
- •- Myelodysplastic syndrome
- •- Elevated liver enzymes
- •- Hereditary Heamochromatosis
- •- Thalassemia
- •- Hemolytic anemia/ chronic hemolysis
研究者
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