Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage: A Double-Blind, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Re-bleeding
研究概览
简要总结
Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments. Although new drugs and endoscopic techniques were easily applied in various settings in this condition, the role of local administered therapies such as antifibrinolytic agents remain unclear. The investigators aimed to compare standard therapy (proton pump inhibitors, endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in upper gastrointestinal hemorrhage in a double-blind, randomized trial.
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, Care Provider)
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
- •Patients presenting with upper gastrointestinal hemorrhage to the ED
- •Patients older than 18 years
- •Patients who agree to participate the study by reading and signing the informed consent form
排除标准
- •Patients younger than 18 years
- •Patients who do not agree to participate the study
- •Documented or declared allergy to tranexamic acid
- •Upper gastrointestinal hemorrhage secondary to trauma
- •Upper gastrointestinal hemorrhage secondary to esophageal varices
- •Patients who cannot undergo to endoscopy for any reason
- •History for thromboembolic disease
- •Patients with renal impairment
研究组 & 干预措施
Tranexamic acid 5%
Tranexamic acid 5%, 2000 mg (40 mL) in 60 mL normal saline (0.9%) solution (total 100 mL)
干预措施: Tranexamic acid 5% (Drug)
Placebo
0.9% normal saline solution (total 100 mL)
干预措施: Placebo (Drug)
结局指标
主要结局
Re-bleeding
时间窗: One month
Recurrent upper gastrointestinal hemorrhage
Mortality
时间窗: One month
In- or out of hospital mortality
Endoscopic intervention need
时间窗: One month
Surgical intervention need
时间窗: One month
ED revisit
时间窗: One month
次要结局
- Adverse reactions(One month)
- Length of stay in the hospital(One month)
- Administered blood products in the ED(One month)
研究者
Nurettin Özgür Doğan
M.D., Associate Professor
Kocaeli University