Recruiting
Phase 2

Tranexamic Acid

Sponsor:

University of Manitoba

Code:

NCT06599762

Conditions

Myelodysplastic Syndromes

Acute Myeloid Leukemia

Myelodysplastic/Myeloproliferative Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tranexamic acid

Placebo

Study Details

Brief 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.

Conditions

Myelodysplastic Syndromes

Acute Myeloid Leukemia

Myelodysplastic/Myeloproliferative Neoplasm

Study ID

NCT06599762

Start date

Sep 10, 2025

Status verified date

Sep, 2025

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Master platform inclusion criteria:

1. Age ≥ 18 years
2. Diagnosis of myelodysplastic syndromes, myelodysplastic/myeloproliferative neoplasm or acute myeloid leukemia

MYELO-CAN TXA inclusion criteria:

1. Receipt of less-intensive chemotherapy (includes both frontline and relapsed/refractory setting)
2. Severe thrombocytopenia (platelets ≤ 30x10\^9/L or platelets ≤ 50x10\^9/L prior to chemotherapy initiation)

Exclusion Criteria:

Master platform exclusion criteria:

1. Participant is deemed unlikely to survive >30 days (as determined by clinical team)
2. Participant unable to provide informed consent

MYELO-CAN TXA exclusion criteria:

1. Known allergy to tranexamic acid
2. Active thromboembolic disease
3. Active ischemic heart disease
4. Gross hematuria
5. Stage V chronic kidney disease
6. Clinically suspected disseminated intravascular coagulation (DIC)
7. Pregnancy and/or breastfeeding

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tranexamic Acid

placebo comparator: Matching Placebo

Interventions

Tranexamic acid

Tranexamic acid 1000mg orally two or three times daily

Placebo

Placebo orally two or three times daily

Primary outcome measure

  • Patient enrollment feasibility [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Locations

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

More Information

Sponsor

University of Manitoba

Last update posted

Apr 22, 2026

Last verified

Sep, 2025

Keywords

  • Tranexamic Acid
  • Randomized Controlled Trial
  • Myelodysplastic Syndrome
  • Acute Myeloid Leukemia
  • Thrombocytopenia
  • myelodysplastic/myeloproliferative neoplasm
  • myeloproliferative neoplasm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-04-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.