Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia

Sponsor
University of Manitoba
Study ID
NCT06599762
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tranexamic acid — DRUG
    Tranexamic acid 1000mg orally two or three times daily
  • Placebo — DRUG
    Placebo orally two or three times daily

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
Sep 10, 2025
Status verified
Sep 2025
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tranexamic Acid
  • Placebo Comparator: Matching Placebo

Primary Outcome Measure

Patient enrollment feasibility [ Time Frame: 2 months ]

Central Contacts

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