VPB0637 - Comparison between Intermittent Bolus versus Continuous Intravenous Infusion of Tranexamic Acid in Hematological Disorders with Thrombocytopenia (BRAVE Trial)

Background: Anti-fibrinolytic agents like tranexamic acid (TXA) have been shown to be effective in preventing bleeding complications in a variety of hemostatic challenges. The elimination half-life is approximately two hours and there are fewer studies comparing bolus and continuous infusions in bleeding disorders in hematology. This study focuses on comparing the intermittent bolus dosage and continuous infusions in different bleeding scenarios in hematology.

Aims: To compare the efficacy of continuous infusion of Tranexamic acid over intermittent bolus dosages in hematological disorders with thrombocytopenia. To study difference in the number of bleeding events, grade of bleeding, the number of platelet transfusions given, and duration of the hospital stay between the arms.

Methods: It was a prospective, randomized, open-label, interventional study. Adult patients aged 18 years or more having a confirmed diagnosis of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Immune thrombocytopenia and Aplastic anemia with a platelet count below 20000/cu mm were taken as study subjects.

Results: A total 35 patients were included in the study. 17 (49%) patients were randomized to bolus arm and 18 (51%) patients were randomized to continuous infusion arm. Study population included 14 (40%) females, 21 (60%) males and were diagnosed to have 16 AML, 9 ALL, 7 ITP and 3 Aplastic anemia. The median age of the patients in the bolus arm was 40 (Q1,Q3, 32,49.5) and in continuous infusion arm was 35 (Q1,Q3, 49,72). Baseline characteristics were matched between the study arms with regard to gender, HB, TLC, PLT count, coagulation parameters. There were no significant difference between the two arms in terms of grade of bleeding (P=0.29), duration of bleeding (p=0.469), number of platelet transfusions (p=0.65), PRBC transfusions (p=0.407) and duration of hospital stay (p=0.508).

Conclusion(s): Bolus dosing of tranexamic acid is as effective as continuous infusion for prophylactic use in thrombocytopenic patients with hematological disorders.