Efficacy of Vonoprazan Versus Intravenous Proton Pump Inhibitors for Prevention of Rebleeding in High Risk Peptic Ulcers Bleeding After Successful Endoscopic Hemostasis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Rebleeding rate
研究概览
简要总结
Upper gastrointestinal hemorrhage (UGIH) is common urgency condition.The estimate mortality rate about 7 percent from peptic ulcers disease(PUD). A proton pump inhibitors (PPIs) intravenous infusion are standard treatment for high risk ulcer bleeding. Vonoprazan,subclass of potassium-competitive acid blockers (P-CABs), have beneficial effects including rapid, long-lasting and strong acid suppression.The investigators design a randomized-controlled trial comparison between 72 hours of intravenous PPIs infusion and oral vonoprazan in high risk ulcer UGIH after achieve endoscopic hemostasis. Outcome measurement are re-bleeding rate in 30 days as primary and re-bleeding rate in 3 days, 30 days mortality, rate of angioembolisation, unit of blood transfusion, hospital cost and length of stay as secondary outcome.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High risk peptic ulcers bleeding (Forrest class Ia,Ib,IIa,IIb)
排除标准
- •Patients were not achieve endoscopic hemostasis
- •End stage cancer disease
- •Severe critical illness and ICU setting
- •Uncorrectable coagulopathy
- •Pregnancy or breast feeding
- •Allergy to PPIs or Vonoprazan
研究组 & 干预措施
Vonoprazan
Vonoprazan 20 mg oral every 12 hours (total 72 hours) then vonoprazan 20 mg oral once daily for 28 days
干预措施: Vonoprazan (Drug)
PPIs
PPIs IV infusion for 72 hours then oral PPIs twice per day for 28 days
干预措施: PPIs IV infusion (Drug)
结局指标
主要结局
Rebleeding rate
时间窗: 30 days
次要结局
- Rebleeding rate(3 days)
- Mortality rate(30 days)
- Length of stay(Until discharge, assessed up to 30 days)
- Rate of immobilisation or surgery(30 days)
- Number of blood transfusion unit(30 days)
研究者
Uayporn Kaosombatwattana
Lecturer
Mahidol University
