Comparison between Intermittent Bolus Versus Continuous Intravenous Infusion of Tranexamic Acid in Hematological Disorders with Thrombocytopenia (BRAVE TRIAL)- a Randomized, OPEN Label, Single Centre Study

Introduction: Reducing blood loss and optimal patient blood management has been gained significant awareness in the current patient management strategies

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.AIM: To compare the efficacy of continuous intravenous infusion of Tranexamic acid over intermittent bolus dosages in hematological disorders with thrombocytopenia

OBJECTIVE: To study the difference in the number of bleeding events, grade of bleeding events, the difference in the number of platelet transfusions given, duration of the hospital stay of the patients between the randomized groups.

Methods: This study was conducted as a prospective, randomized, open-label, interventional study at a tertiary

care center. Block randomization and allocation concealment was done using sequentially numbered, opaque sealed envelopes (SNOSE) and monitored by the central coordinator

Inclusion Criteria: Subjects aged > 18 y, who were eligible for the study if they have a confirmed diagnosis of one of the following hematological disorders and with a platelet count below 20000/cu mm

Acute myeloid leukemia

Acute lymphoblastic leukemia

Aplastic anemia

Immune thrombocytopenia

Exclusioncriteria: Patients with previous history or current diagnosis of arterial or venous thromboembolic disease, diagnosis of APML and undergoing induction chemotherapy, history of allergy to TXA.

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 (p>0.05) 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).

CONCLUSIONS: There was no significant difference in between the two arms in terms of grade of bleeding, duration of bleeding, number of platelet, PRBC transfusions used and also in the duration of hospital stay.

Therewas trend for higher number of platelet transfusions, more number of bleeding events, increased duration of bleeding and hospital stay in the bolus arm in comparison to the continuous infusion arm. However, this was not statistically significant.

Toconclude, prophylactic bolus dosing of tranexamic acid is as effective as continuous infusion in patients with hematological disorders.REFERENCES 1.Gernsheimer TB, Brown SP, Triulzi DJ, Key NS, El Kassar N, Herren H, et al. Effects of tranexamic acid prophylaxis on bleeding outcomes in hematologic malignancy: the a-TREAT trial. Blood. 2020;136:1-2.

2.Carson JL, Stanworth SJ. Anemia and bleeding in thrombocytopenic patients. Blood. 2017;130:1178-9

No relevant conflicts of interest to declare.