Tranexamic Acid for Acute Upper Gastrointestinal Bleed in Cirrhosis - A Randomized Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Proportion of patients developing five-day treatment failure in both the groups
研究概览
简要总结
The management of acute upper gastrointestinal bleeding (UGIB) is challenging in patients with cirrhosis, as it is responsible for severe complications and high mortality rates. Fibrinolytic activity of the epithelial surfaces and of the submucosal blood vessels may interfere with hematemesis and even delay healing of ulcers. Tranexamic acid (TXA) may help control the bleeding by counterbalancing cirrhosis-related hyperfibrinolysis. Still, there is a lack of unbiased data to conclude on its efficacy. Tranexamic Acid in patients with acute Upper Gastrointestinal bleed have been shown to prevent re bleed in few studies when combined with standard medical management (which generally comprises of initial fluid resuscitation, intravenous PPI , splanchnic vasoconstrictors, blood transfusions and coagulopathy corrections as per lab parameters) but no randomized placebo controlled trial has been done. The aim of this study is to evaluate the efficacy of TXA in the early treatment of acute UGIB as compared to placebo in patients with cirrhosis.
详细描述
Aim and Objective - AIM- To compare the efficacy and safety of tranexamic acid in reducing 5-day treatment failure (i.e., failure to control bleed) in patients with cirrhosis presenting with Upper GI bleed
Primary Objective:
Proportion of patients developing five-day treatment failure (i.e., failure to control bleed)
Secondary Objectives:
- Failure to prevent rebleed within 6 weeks
- Clinically significant rebleed within 6 weeks (monitored by hemoglobin drop by 3g/dl, need of blood transfusion)
- Need for salvage therapy (tamponade, additional endoscopic therapy, TIPS, surgery etc.)
- Blood product and component requirements
- Days of ICU/hospital stay
- Thromboembolic events (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction etc)
- Other complications post bleed (including other significant cardiac event, sepsis, pneumonia, respiratory failure, Acute Kidney Injury, seizures etc)
- Mortality attributed to failure to control bleed.
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, 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 greater than 18 years of age
- •Presenting with Acute UGI bleed (< 24hrs from onset).
- •Cirrhosis (Known Or suspected on clinical, biological, radiological data or the patient's history) with CTP B / C (i.e. CTP >/=7) or ACLF (with clinical evidence of cirrhosis).
排除标准
- •Non cirrhotic patients
- •Known allergy to Tranexamic Acid
- •Patients with clinical evidence of DIC (Disseminated Intravascular Coagulation) like coagulopathy patches/ haematuria / uncontrolled epistaxis etc.
- •Patients with Chronic Kidney Disease.
- •History of recent Cerebro Vascular Accident (CVA) [in the past 6 months] or patients with thrombotic events [Portal Vein thrombosis /Hepatic vein thrombosis /other sites thrombosis]. HCC with tumour thrombosis will be included
- •Any history of seizures, myocardial infarction
- •Pregnancy/lactation
研究组 & 干预措施
Tranexamic Acid with Standard Medical Treatment
Arm A will Tranexamic Acid 1g iv bolus as loading dose followed by 3g Tranexamic Acid infused over next 24 hours along with standard medical and interventional (Endoscopy) therapy.
干预措施: Tranexamic acid (Drug)
Tranexamic Acid with Standard Medical Treatment
Arm A will Tranexamic Acid 1g iv bolus as loading dose followed by 3g Tranexamic Acid infused over next 24 hours along with standard medical and interventional (Endoscopy) therapy.
干预措施: Standard Medical Treatment (Other)
Placebo + Standard Medical treatment
Arm B will receive similar volume of isotonic solution (saline) along with standard medical and interventional (Endoscopy) therapy.
干预措施: Standard Medical Treatment (Other)
Placebo + Standard Medical treatment
Arm B will receive similar volume of isotonic solution (saline) along with standard medical and interventional (Endoscopy) therapy.
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of patients developing five-day treatment failure in both the groups
时间窗: 5 day
次要结局
- Number of patients with failure to prevent rebleed in both group(6 weeks)
- Number of patients with stroke in both groups(6 weeks)
- Clinically significant rebleed in both groups(6 weeks)
- Number of patients who will require salvage therapy in both groups(6 weeks)
- Number of patients who will require Blood product and component in both groups(6 weeks)
- Number of days in Intensive Care Unit in both groups(6 weeks)
- Number of days in hospital in both groups(6 weeks)
- Number of patients with deep vein thrombosis in both groups(6 weeks)
- Number of patients with pulmonary embolism in both groups(6 weeks)
- Number of patients with myocardial infarction in both groups(6 weeks)
- Number of patients with Adverse Events associated with post bleed in both groups(6 weeks)
- Number of patients with Mortality attributed to failure to control bleed in both groups(6 weeks)