Background: Bleeding is a common issue among patients with hematological malignancies undergoing intensive therapy. The TREATT trial aimed to evaluate the effectiveness of tranexamic acid in preventing bleeding and reducing the need for platelet transfusions.
Methods: Conducted across 27 haematology centers in Australia and the UK, the trial enrolled adults aged 18 years or older receiving intensive chemotherapy or haematopoietic stem-cell transplantation for a hematological malignancy. Participants with a platelet count of 10 × 10^9 platelets per L or less for 5 days or longer were randomly assigned to receive either tranexamic acid or placebo. The primary endpoint was the proportion of patients who died or experienced WHO grade 2 or higher bleeding up to day 30.
Findings: Out of 1736 screened patients, 616 were enrolled and randomly assigned to either tranexamic acid or placebo. The analysis included 300 participants in the tranexamic acid group and 297 in the placebo group. The study found no significant difference in the proportion of participants who died or had WHO grade 2 or higher bleeding between the two groups. Additionally, there were no differences in thrombotic events or veno-occlusive disease. The trial reported 94 serious adverse events in the tranexamic acid group and 103 in the placebo group up to day 60.
Interpretation: The results suggest there is insufficient evidence to support the routine use of tranexamic acid for reducing bleeding in patients with hematological malignancies undergoing intensive chemotherapy.
