Tranexamic acid in upper gastrointestinal bleed in patients with cirrhosis - a randomized controlled trial

Background and aims:Patients with Child-Turcotte-Pugh (CTP) class B and C cirrhosis with upper GI bleeding (UGIB) have systemic as well as localized (in the mucosa of oesophagus and stomach) fibrinolysis. The aim of this study was to evaluate the efficacy and safety of tranexamic acid in treatment of acute UGIB in patients with cirrhosis. Methods:A total of 600 patients with advanced liver cirrhosis (CTP class B or C) presenting with UGIB were randomly allocated to either tranexamic acid (n=300) or placebo group (n=300). The primary outcome measure was the proportion of patients developing five-day treatment failure. Results:Failure to control bleeding by day 5 was seen in 19/300 (6.3%) patients in the tranexamic acid group and 40/300 (13.3%) patients in the placebo group [p=0.006]. Esophageal EVL site as source of failure to control bleeding by day 5 among patients undergoing first time esophageal EVL (excluding patients with previous post EVL ulcer as source of bleed) was seen in s in 11/222 (4.9%) in tranexamic acid group and 27/225 (1212.0%) in placebo group [p=0.005]. However, 5-day and 6 week mortality was similar in the tranexamic acid and placebo groups. Conclusion:Tranexamic acid significantly reduces the failure to control bleeding by day 5 and failure to prevent rebleeding after day 5 till 6 weeks in patients with advanced liver cirrhosis (CTP class B or C) presenting with UGIB, by preventing bleeding from EVL site.