NCT01560702已完成不适用
Endoscopic Injection of Autologous Blood Versus Diluted Epinephrine for Control of Actively Bleeding Gastroduodenal Ulcers
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure.
研究概览
简要总结
Endoscopic injection of autologous blood can control bleeding from gastroduodenal ulcers.
详细描述
To test the hypothesis that endoscopic injection of autologous blood is superior to endoscopic injection of diluted epinephrine in controlling bleeding from gastroduodenal ulcers.
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
- None
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all adult patients with gastroduodenal ulcer
排除标准
- •Patients with non ulcer bleeding.
- •Patients with malignancy.
- •Patients with bleeding disorders or under coagulation therapy.
- •Patients with known allergy to epinephrine.
研究组 & 干预措施
Autologous blood
Active Comparator
Patients will be injected by autologous blood at the edge of actively bleeding ulcer
干预措施: Blood (Biological)
Epinephrine injection
Other
Patients will be injected by diluted epinephrine at the edge of actively bleeding ulcer
干预措施: Epinephrine (Drug)
结局指标
主要结局
hemostasis from the ulcer after injection and/or stoppage of haematemesis and melena one day after the procedure.
时间窗: 12 months
次要结局
- development of re-bleeding after 24 hours after the procedure (occurrence of hematemesis or melena or drop of hemoglobin level >2gm/dl).(12 months)
研究者
Moahmed Hassan Emara
Lecturer
Zagazig University
研究点 (1)
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