TREATT Trial Evaluates Tranexamic Acid for Bleeding Prevention in Patients with Hematologic Malignancies, Thrombocytopenia

By Melissa Badamo - Last Updated: February 4, 2025

A study published in The Lancet Haematology evaluated the use of tranexamic acid for bleeding prevention in patients with hematologic malignancies and severe thrombocytopenia undergoing intensive chemotherapy.

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The randomized, double-blind, parallel, phase III superiority trial included adult patients from 27 hematology centers in the United Kingdom and Australia. Patients had received prior intensive chemotherapy or hematopoietic stem cell transplantation and had a platelet count of 10×109/L for at least five days.

Patients were randomly assigned to tranexamic acid (1 g every 8 hours intravenously or 1.5 g every 8 hours orally; n=300) or placebo (n=297) when their platelet count was lower than 30×109/L and continued treatment until 30 days or until they achieved platelet recovery. Patients also received standard-of-care prophylactic platelet transfusions.

The primary endpoint was the percentage of patients who died or experienced grade 2 or higher bleeding up to day 30 according to the World Health Organization Bleeding Scale. Ninety patients (31.7%) who received tranexamic acid died or experienced grade 2 or higher bleeding, compared with 98 patients (34.2%) who received placebo (P=·62). The researchers cited no differences in thrombotic events or veno-occlusive disease between the two groups. There were 94 serious adverse events among 77 patients receiving tranexamic acid and 103 events among 82 patients receiving placebo up to day 60.

“There is insufficient evidence to support routine use of tranexamic acid to reduce bleeding in patients with haematological malignancies undergoing intensive chemotherapy,” the researchers concluded.

Reference

TREATT Trial Investigators. Tranexamic acid versus placebo to prevent bleeding in patients with haematological malignancies and severe thrombocytopenia (TREATT): a randomised, double-blind, parallel, phase 3 superiority trial. Lancet Haematol. 2025;12(1):e14-e22. doi:10.1016/S2352-3026(24)00317-X

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