A randomized controlled trial of the effects of local tranexamic acid on mortality, rebleeding, and recurrent endoscopy need in patients with upper gastrointestinal hemorrhage.

Objective: Tranexamic acid (TXA) is an antifibrinolytic agent used to control bleeding in different circumstances. We conducted a randomized controlled trial to assess the efficacy and safety of locally administered TXA in upper gastrointestinal hemorrhage.

Methods: This single-center, double-blind, randomized controlled trial was performed in a tertiary emergency department (ED) in patients presenting with upper gastrointestinal bleeding symptoms between 2016 and 2018. The patients received either 2000 mg of 5% TXA in 100 mL of isotonic saline solution or 100 mL isotonic saline (control group) via the nasogastric route. As a composite outcome, recurrent endoscopy need, rebleeding, surgery need, recurrent admission to the ED, and mortality parameters were evaluated at the end of a one-month period.

Results: During the study period, 78 patients were randomized into the TXA group, and 79 patients were randomized into the isotonic saline group. The majority of the bleedings (61%) were in Forrest class 3, and the most frequent cause was peptic ulcer disease. The composite outcome occurred in 25 of the TXA patients (32.1%) and 23 of the isotonic saline patients (29.1%); no statistically significant difference was found between the groups (P = 0.690). In addition, no statistically significant differences were observed between the TXA and control groups regarding mortality (10.3 vs 12.7%; P = 0.637), recurrent ED admission (17.9 vs 12.7%; P = 0.357), or thromboembolic complications (3.8 vs 1.3%; P = 0.367).

Conclusion: Locally administered TXA confers no additional benefit over standard care in patients with upper gastrointestinal hemorrhage.