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Tranexamic acid in upper gastrointestinal bleed in patients with cirrhosis: A randomized controlled trial

Manoj Kumar1, Shantan Venishetty1, Ankur Jindal1

  • 1Department of Hepatology and Liver Transplantation, Institute of Liver & Biliary Sciences, New Delhi, India.

Hepatology (Baltimore, Md.)
|March 5, 2024
PubMed

Insights

Tranexamic acid effectively treats upper gastrointestinal bleeding in advanced cirrhosis patients. It significantly reduces bleeding by day 5 and rebleeding, particularly from the esophageal variceal ligation site.

Area of Science:

  • Gastroenterology
  • Hepatology
  • Pharmacology

Background:

  • Patients with advanced cirrhosis (Child-Turcotte-Pugh class B/C) experiencing upper gastrointestinal bleeding (UGIB) exhibit both systemic and localized fibrinolysis.
  • Localized fibrinolysis occurs in the esophageal and gastric mucosa.

Purpose of the Study:

  • To assess the efficacy and safety of tranexamic acid in managing acute UGIB in patients with cirrhosis.
  • To determine if tranexamic acid can reduce treatment failure and rebleeding in this patient population.

Main Methods:

  • A randomized controlled trial involving 600 patients with advanced cirrhosis (Child-Turcotte-Pugh class B or C) and UGIB.
  • Patients were allocated to receive either tranexamic acid (n=300) or a placebo (n=300).
  • The primary outcome was 5-day treatment failure; secondary outcomes included bleeding from the esophageal variceal ligation (EVL) site and mortality.

Main Results:

  • Treatment failure by day 5 occurred in 6.3% of the tranexamic acid group versus 13.3% in the placebo group (P=0.006).
  • Bleeding from the EVL site by day 5 was significantly lower in the tranexamic acid group (4.9%) compared to placebo (12.0%) (P=0.005).
  • Mortality rates at 5 days and 6 weeks were similar between the tranexamic acid and placebo groups.

Conclusions:

  • Tranexamic acid significantly reduces treatment failure by day 5 in patients with advanced cirrhosis and UGIB.
  • The drug is effective in preventing rebleeding from the EVL site between day 5 and 6 weeks.
  • Tranexamic acid demonstrates a favorable safety profile with similar mortality rates to placebo.
Abstract

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