The Use of Hexacapron in Upper Gastrointestinal Bleeding
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Prevention of rebleeding manifested as hematemesis, melena and drop in hemoglobin level by 2g% within 24 hours after therapeutic endoscopy
研究概览
简要总结
The purpose of this study is to conduct a randomized control trial, double-blind study to compare Hexacapron with standard of care treatment to standard of care alone to evaluate the efficacy of adding effect of Hexacapron to standard therapy by decreasing the episodes of rebleeding and mortality in patient with upper gastrointestinal bleeding.
详细描述
Research Objectives
To evaluate the efficacy of using hexacapron in treatment of upper gastrointestinal bleeding
- Primary outcome: Prevention of rebleeding manifested as hematemesis, melena and drop in hemoglobin level by 2g% within 24 hours after therapeutic endoscopy
- Secondary outcomes: rebleeding, need for surgery , 30 day mortality
Expected Significance- The sample size needed to detect a 10% absolute difference in the proportion of rebleeding, drop in hemoglobin by 2g% between the hexacapron treated group and standard of care group groups with 80% power and 0.05 significant levels(alpha).
Research methods:
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
- Triple (Participant, Care Provider, 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
- •Patients 18≤ years of age admitted to emergency department in Shaare Zedek MedicalCenter with clinical signs, symptoms and laboratory of upper gastrointestinal bleeding
- •Hospitalized patients in Shaare Zedek Medical Center with clinical signs, symptoms and laboratory of upper gastrointestinal bleeding
- •Patients , guardian or family member who can sign on informed consent
排除标准
- •Pregnancy, lactation
- •History of thromboembolic event
- •Allergic reaction to the drug
- •Lower gastrointestinal bleeding
- •Patient receive anticoagulation treatment
- •Receive drug with interaction to hexacapron
研究组 & 干预措施
Treatment group, hexacapron , esomeprazole
Treatment group - receive I.V. esomeprazole 80 mg and 8mg/h continuously with concurrent hexacapron I.V. every 6 hours until 72 hours and then continue oral treatment 6 g /day for 7 days.
干预措施: Hexacapron( Tranexamic acid) (Drug)
Standard of care group, esomeprazole
* Standard of care group - receive I.V. esomeprazole 80 mg once then 8mg/h continuously
干预措施: esomeprazole (Drug)
结局指标
主要结局
Prevention of rebleeding manifested as hematemesis, melena and drop in hemoglobin level by 2g% within 24 hours after therapeutic endoscopy
时间窗: Will be assessed 48 hours after admission to hospital
All patients will undergo upper endoscopy within 12 hours from admission to assess their cause of upper GI bleeding .Patients will be evaluated according to the intervention group or standard of care group if there is another episode of bleeding or not during the first 48 hours after the first bleeding episode or within 24 hours after the first endoscopy was done
次要结局
- Rebleeding, need for surgery , 30 day mortality(will be assessed after 30 days from admission to hospital)
研究者
Dr Bernardo Melamud
Dr.Bernardo Melamud
Shaare Zedek Medical Center