A randomized, double-blind clinical trial was conducted to determine the effectiveness of prophylactic tranexamic acid (TXA) in reducing bleeding incidence among patients undergoing treatment for hematologic malignancies. The trial, which ran from June 2016 through June 2020, enrolled 356 eligible patients out of 3120 screened adults. Patients were randomized to receive either 1300 mg TXA orally or 1000 mg TXA intravenously (n = 168) versus placebo (n = 169) thrice daily for a maximum of 30 days.
Among the 337 patients (mean age, 53.9; 141 [41.8%] women) who participated, 330 were activated when their platelet counts fell below 30,000 per µL, with 279 (83%) having complete outcome ascertainment. The study observed World Health Organization (WHO) grade ≥2 bleeding in 50.3% (73/145) of the TXA group and 54.2% (78/144) of the placebo group within 30 days following activation, with an adjusted odds ratio of 0.83 (95% confidence interval [CI], 0.50-1.34; P = .44).
No statistically significant differences were found in the mean number of platelet transfusions, mean days alive without grade ≥2 bleeding, thrombotic events, or deaths due to serious bleeding between the TXA and placebo groups. The most common adverse events included diarrhea, febrile neutropenia, fatigue, and nausea, with similar incidences in both groups.
The study concluded that among patients with hematologic malignancy undergoing chemotherapy or hematopoietic stem cell transplantation, prophylactic treatment with TXA compared with placebo did not significantly reduce the risk of WHO grade ≥2 bleeding.
