NCT00978575已完成4 期
Comparison of the Efficacy of Compliant Oral Iron Treatment (FerroDuretter ®) for 3 Months After Discharge Versus Single-dose of Intravenous Iron (Ferinject ®) Before Discharge in Patients With Acute Bleeding From Upper Gastrointestinal Tract. A Double Blinded Randomized Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- haemoglobin
研究概览
简要总结
The trial is a double-blind randomized trial designed to examine whether compliant iron therapy (intravenous or oral) for 3 months after discharge increases hemoglobin levels more and faster than no treatment - in patients with acute bleeding from upper gastrointestinal tract. The trial will include 126 patients at Aarhus University Hospital. In addition to efficacy assessment quality of life assessment and health economic calculations between the treatments will be compared.
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
- Double (Participant, Investigator)
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
- •Acute upper gastrointestinal bleeding
排除标准
- •Liver disease
- •Terminal cancer
- •Kidney disease
- •variceal bleeding
- •Pregnancy
研究组 & 干预措施
Intravenous iron
Active Comparator
干预措施: ferricarboxymaltose (Drug)
Oral iron
Active Comparator
干预措施: Ferrosulfate (Drug)
Isotonic Sodium and placebo tablets
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
haemoglobin
时间窗: 13 weeks
次要结局
- Quality of life Health economics(13 weeks, 6 and 12 months)
研究者
Palle Bager
Clinical Nurse Specialist, RN, MPH
University of Aarhus
研究点 (1)
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