Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are serious, life changing blood cancers. Patients with MDS and AML commonly experience complications related to bleeding, which affect patient quality-of-life and can sometimes lead to hospitalization or death. The investigators will conduct a randomized controlled trial to evaluate the effectiveness and safety of tranexamic acid (TXA; a medication that prevents clots from dissolving) to prevent bleeding. In this study, 50% of patients will be randomized (like the flip of a coin) to receive TXA; the other 50% of patients will receive placebo. The investigators will monitor both groups of patients to see if the medication improves the risk and/or severity of bleeding. If tranexamic acid were to safely reduced the frequency of bleeding, this would broadly influence how doctors provide care for patients with MDS and AML around the world.
Age ≥ 18 years
Diagnosis of myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm or acute myeloid leukemia
Receipt of less-intensive chemotherapy (includes both frontline and relapsed/refractory setting)
Severe thrombocytopenia (platelets ≤ 30x10^9/L or platelets ≤ 50x10^9/L prior to chemotherapy initiation)
Participant is deemed unlikely to survive >30 days (as determined by clinical team)
Participant unable to provide informed consent
Known allergy to tranexamic acid
Active thromboembolic disease
Parallel
Tranexamic acid
DrugTranexamic acid 1000mg orally two or three times daily
Placebo
DrugPlacebo orally two or three times daily
Patient enrollment feasibility
The ability to enroll a median of 1 patient per site per month (10 patients / month when all sites are active)
Venous or arterial thromboembolism incidence
The incidence of venous or arterial thromboembolism will be measured as a safety outcome.
Catheter-associated thrombosis incidence
The incidence of catheter-associated thrombosis will be measured as a safety outcome.
Study drug discontinuation
Study drug discontinuation due to adverse events will be measured as a safety outcome.
Ability to consent 30% of eligible patients
The ability to consent 30% of eligible patients will be measured as a feasibility outcome.
Quality of life evaluation using PROMIS questionnaire
Quality of life evaluation at baseline and monthly using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue SF7a patient questionnaire.
Quality of life evaluation using EORTC questionnaire
Quality of life evaluation at baseline and monthly using the Core Quality of Life Questionnaire of the European Organisation For Research And Treatment Of Cancer (EORTC) C30 questionnaire.
Grade 2 to 5 bleeding incidence
The incidence of World Health Organization (WHO) defined grade 2 to 5 bleeding will be measured as a tertiary clinical outcome.
WHO bleeding incidence
The incidence of World Health Organization (WHO) bleeding stratified by grade will be measured as a clinical outcome.
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