Objectives

To determine whether tranexamic acid, an antifibrinolytic, could safely reduce bleeding incidence and transfusion requirements in individuals undergoing treatment for hematologic malignancies.

Background

Survival rates for individuals with hematologic malignancies have improved with aggressive therapy but require substantial transfusion support. Antifibrinolytics are commonly used to prevent and treat bleeding in patients with platelet function disorders and inherited coagulopathies. However, there is limited information about the effectiveness of antifibrinolytics in patients who are thrombocytopenic due to primary bone marrow disorders or chemotherapy, immunotherapy and/or radiation therapy.

The A-TREAT study was initiated to determine if the antifibrinolytic tranexamic acid (TXA) could safely reduce bleeding incidence and transfusion requirements in individuals undergoing treatment for hematologic malignancies.

Participants

Eligible participants were adults with a diagnosis of a hematologic malignancy or aplasia; were undergoing chemotherapy, immunotherapy, or hematopoietic stem cell transplant; and were anticipated to have hypoproliferative thrombocytopenia resulting in a platelet count of ≤10,000 per µL for ≥5 days. Exclusion criteria included anticoagulant use and a history of venous or arterial thromboembolism.

A total of 337 participants were randomized, 169 to the placebo group and 168 to the TXA group. Of those, 165 participants in each treatment group were activated.

Design

A-TREAT was a multicenter, double-blinded placebo-controlled randomized clinical trial. When platelet counts fell below 50,000 per μL, patients were randomized to either TXA or placebo. Randomization was stratified according to clinical site and disease group (allogeneic transplant, autologous transplant, or chemotherapy for hematologic malignancy). When the platelet count fell below 30,000 per µL, patients who had not developed contraindications to treatment were activated to the treatment phase and received TXA (either oral 1.3 g or IV 1.0 g every 8 hours) or matched placebo in a double-blind fashion. Patients were treated with a prophylactic platelet transfusion once their platelet count fell below 10,000 per µL or at clinician discretion.

Outcomes and safety data were collected for 30 days after activation or discontinuation. Laboratory values and transfusion data were collected daily while inpatient and twice weekly while outpatient. Bleeding assessments, adapted from the WHO bleeding scale, and a thrombotic review were completed daily by an observer on inpatients and through diaries on outpatients.

The primary outcome was the incidence of bleeding of WHO grade ≥2 during the first 30 days after activation.

Conclusions

Among individuals with a 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.

Gernsheimer TB, Brown SP, Triulzi DJ, et al. Prophylactic tranexamic acid in patients with hematologic malignancy: a placebo-controlled, randomized clinical trial. Blood. 2022;140(11):1254-1262. doi:10.1182/blood.2022016308

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