Tranexamic acid is often used to reduce bleeding, particularly after surgery and may reduce bleeding-related death in patients with trauma. It remains unclear if tranexamic acid reduces deaths in patients who present with acute GI bleeding.
An international, multicenter, randomized, placebo-controlled trial examined this question. Adult patients with acute GI bleeding were randomly assigned to either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). The primary outcome was death due to bleeding within 5 days of randomization. 12 009 patients were randomly allocated to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%).
Death due to bleeding within 5 days of randomization occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82-1·18).
Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39).
Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98).
In other words, this large clinical trial showed that tranexamic acid did not reduce death from gastrointestinal bleeding but may result in higher venous thromboembolic events. Thus, IV tranexamic acid is not useful in patients with acute GI bleeding.
