Early Administration of Intravenous Tranexamic Acid for Upper Gastrointestinal Bleeding Prior to Endoscopy
试验速览
- 阶段
- 3 期
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Proportion of patients requiring early endoscopic treatment
研究概览
简要总结
This study is to see whether the early intravenous administration of tranexamic acid improves the outcome of acute upper gastrointestinal bleeding.
详细描述
Previous studies reported that IV/Oral administration of tranexamic acid improves the outcome upper gastrointestinal bleeding. However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm. Although a recent meta-analysis done by Cochrane review group concluded that it improves patient survival, other review articles including "Gut" suggested that a well-designed clinical study is needed for re-evaluation of the efficacy and safety of the drug in current clinical situation. We hypothesized that early administration of the drug will significantly decrease the proportion of patient requiring early endoscopic treatment.
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
- •Chief complaint of hematemesis, melena or hematochezia
- •and objective signs of upper gastrointestinal bleeding
排除标准
- •Pregnant woman, age less than 18
- •Patients whose use of the study drug is contraindicated
- •Increased thromboembolic risk
- •History of thromboembolic disease
- •Alleged inherited thrombophilic disorders
- •Malignancy (except those cured and has not recurred more than two years)
- •Nephrotic syndrome
- •Estrogen use
- •Pregnancy
- •High-risk for cardioembolism
- •Underlying structural heart disease where anticoagulation is indicated
- •Underlying cardiac rhythm disorder where anticoagulation is indicated (e.g. atrial fibrillation/flutter)
- •Possibilities of ongoing DIC
- •Signs and symptoms suggestive of clinically significant infectious disease (e.g. body temperature > 38 degree)
- •Any malignancy except those cured and has not recurred more than two years
- •Patients with history or presence of subarachnoid hemorrhage
- •Acquired color vision impairment, visual loss and retinal venous and arterial occlusions
- •Past history of seizure or organic brain lesion that predispose to seizure disorder
- •Previous history of variceal bleeding
- •Cases where informed consent is unobtainable
研究组 & 干预措施
Early intravenous tranexamic acid administration
Early intraveous administration of tranexamic acid
(1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours
干预措施: Early intravenous tranexamic acid administration (Drug)
Placebo group
Normal saline (placebo) administration instead of tranexamic acid solution
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of patients requiring early endoscopic treatment
时间窗: Within 24 hours of emergency department visit
次要结局
- Need for urgent endoscopy(Within 24 hours of emergency department visit)
- Need for transfusion(Within one-month of emergency department visit)
- thromboembolic complications(Within one-month of emergency department visit)
- Need for surgery/angiographic intervention(Within one-month of emergency department visit)
- Endoscopic signs of bleeding(Within 24 hours of emergency department visit)
- Length of stay(Within one-month of emergency department visit)
- Endoscopic procedure time/difficulty(Within 24 hours of emergency department visit)
- rate of recurrent bleeding(Within one-month of emergency department visit)
- death of any cause(Within one-month of emergency department visit)