Efficacy of tranexamic acid and standard management vs standard management in the control of bleeding in patients with upper gastrointestinal bleed: A double-blinded randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- CONTROL OF BLEEDING
研究概览
简要总结
Upper Gastrointestinal (UGI) bleed is defined as bleeding from the gastrointestinal (GI) tract proximal to the Ligament of Treitz. The incidence of UGI bleed varies from 50-150 / 100,000 per year and is associated with around 10% mortality.
Currently, UGI bleed patients receive octreotide for the reduction of splanchnic blood flow and proton pump inhibitors for the reduction of gastric acid output, along with antibiotics to prevent rebleed and hepatic encephalopathy. Tranexamic acid (TXA) is antifibrinolytic which is being used in controlling bleeding in trauma patients and abnormal uterine bleeding, and it is hypothesised that it can help in controlling upper GI bleed. Early administration of antifibrinolytic agents such as TXA could efficiently help in controlling acute UGI bleed.
Safe pharmacological management for controlling bleeding can significantly reduce the need for surgical interventions, hospital stay and intensive care admissions (ICU) admissions.
The addition of TXA to standard management will decrease the proportionate of patients with active bleeding and rebleeding and thereby reducing the overall requirement of blood transfusion, length of hospital stay, length of ICU stay and overall mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •all patients aged above 18 years with ugi bleed.
排除标准
- 未提供
结局指标
主要结局
CONTROL OF BLEEDING
时间窗: At baseline and then every 12th hourly for 5 days
次要结局
- Reducing the incidence of early re-bleeding (uptill 72 hours)
研究者
PRABHAT KHIRWAR
JIPMER
