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Efficacy of Tranexamic Acid for the Management of Upper Gastrointestinal Bleeding in Patients With Cirrhosis
TAKE-HOME MESSAGE
- This study investigated the efficacy of tranexamic acid in the treatment of upper gastrointestinal bleeding in patients with cirrhosis. A total of 600 patients with Child–Turcotte–Pugh class B or C cirrhosis were randomized to receive either tranexamic acid or placebo, with the primary outcome being the proportion of patients with the absence of bleeding control or re-bleeding by day 5.
- A significantly greater proportion of patients in the placebo group (13.3%) had treatment failure by day 5 than those in the tranexamic acid group (6.3%). The 5-day and 6-week mortality rates were comparable between the two groups.
abstract
This abstract is available on the publisher's site.
Access this abstract nowBACKGROUND AND AIMS
Patients with Child-Turcotte-Pugh class B and C cirrhosis with upper gastrointestinal bleeding (UGIB) have systemic as well as localized (in the mucosa of the esophagus and stomach) fibrinolysis. The aim of this study was to evaluate the efficacy and safety of tranexamic acid in the treatment of acute UGIB in patients with cirrhosis.
APPROACH AND RESULTS
A total of 600 patients with advanced liver cirrhosis (Child-Turcotte-Pugh class B or C) presenting with UGIB were randomly allocated to either the tranexamic acid (n=300) or the placebo group (n=300). The primary outcome measure was the proportion of patients developing 5-day treatment failure. 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 endoscopic variceal ligation (EVL) site as a source of failure to control bleeding by day 5 among patients undergoing first-time esophageal EVL (excluding patients with a previous post-EVL ulcer as a source of bleed) was seen in 11/222 (4.9%) patients in the tranexamic acid group and 27/225 (1212.0%) patients in the placebo group ( p =0.005). However, 5-day and 6-week mortality was similar in the tranexamic acid and placebo groups.
CONCLUSIONS
Tranexamic acid significantly reduces the failure to control bleeding by day 5 and failure to prevent rebleeding after day 5 to 6 weeks in patients with advanced liver cirrhosis (Child-Turcotte-Pugh class B or C) presenting with UGIB, by preventing bleeding from the EVL site.
Additional Info
Disclosure statements are available on the authors' profiles:
Tranexamic acid in upper gastrointestinal bleed in patients with cirrhosis: A randomized controlled trial
Hepatology 2024 Aug 01;80(2)376-388, M Kumar, S Venishetty, A Jindal, C Bihari, R Maiwall, R Vijayaraghavan, S Saggere Muralikrishna, V Arora, G Kumar, SK SarinFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Intravenous tranexamic acid (TXA) has been the focus of several projects including randomized controlled trials and subsequent meta-analyses, likely owing to the known high mortality of acute upper gastrointestinal bleed (UGIB), especially in patients with severely decompensated cirrhosis. Kumar et al present a randomized controlled trial to provide more data on the use of TXA in patients with cirrhosis.
This study expands on previous work to compare placebo and TXA in patients with Child–Turcotte–Pugh B or C cirrhosis with the goal of evaluating the efficacy and safety of TXA in the treatment of acute UGIB in patients with more advanced cirrhosis. The primary endpoint was 5-day treatment failure, also referred to as absence of control of bleeding or re-bleeding within 5 days. There were multiple secondary endpoints including mortality at 5 days and 6 weeks. There was a significant difference between the two groups in the proportion of patients meeting the primary endpoint; however, there was no difference in mortality at 5 days or 6 weeks. Control of bleeding was achieved at a higher rate in the 5-day period following the bleeding event. This may help reduce length of stay and the burden of further procedures. However, this intervention did not seem to change the overall morbidity or possibly the long-term mortality for these patients, and the risk of thromboembolic events was not fully evaluated.
A larger study with careful selection of individuals who undergo TXA therapy with a longer follow-up duration would be helpful in determining whether this intervention is beneficial for long-term survival. If mortality is not reduced, then the potential to worsen a new portal vein thrombosis, a hypercoagulable state from hepatocellular carcinoma, or further disruption to the coagulation profile in patients with severely decompensated cirrhosis may not be worthwhile. It is important to note that patients with hepatocellular carcinoma were included, and enrolled patients did not have assessment for development of new portal vein thrombus as cause of presenting decompensation. As the authors demonstrate, this is an interesting concept that should be investigated further, especially for those who need more rapid correction of their bleeding or those who cannot undergo further invasive procedures, such as TIPS, for management of their portal hypertensive bleeding. It is important to use an individualized approach when encountering acute UGIB in patients with decompensated cirrhosis and complex coagulation physiology, and, as demonstrated by this study, TXA may be a beneficial option in a select group of patients.