RecruitingPhase 2NCT06599762

Evaluation of Tranexamic Acid in Myelodysplastic Syndromes and Acute Myeloid Leukemia

Evaluation of Tranexamic Acid Among Outpatients With Myelodysplastic Syndromes and Acute Myeloid Leukemia: a Multicenter Pilot Trial


Sponsor

University of Manitoba

Enrollment

75 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether tranexamic acid — a medication that helps control bleeding — can reduce dangerous bleeding events in people with certain blood cancers (myelodysplastic syndromes or acute myeloid leukemia) who have very low platelet counts during chemotherapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) - You are receiving less-intensive chemotherapy (either as first-line treatment or for relapsed/refractory disease) - You have very low platelet counts (platelets at or below 50,000) **You may NOT be eligible if...** - Your medical team believes you are unlikely to survive more than 30 days - You are unable to give informed consent - You have a known allergy to tranexamic acid - You currently have an active blood clot (deep vein thrombosis, pulmonary embolism, etc.) - You have active ischemic heart disease - You have blood in your urine - You have end-stage kidney disease - You are suspected of having a condition called disseminated intravascular coagulation (DIC) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTranexamic acid

Tranexamic acid 1000mg orally two or three times daily

DRUGPlacebo

Placebo orally two or three times daily


Locations(1)

CancerCare Manitoba

Winnipeg, Manitoba, Canada

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NCT06599762


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