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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Master platform inclusion criteria:

• Age ≥ 18 years

• Diagnosis of myelodysplastic syndromes or acute myeloid leukemia

⁃ MYELO-CAN TXA inclusion criteria:

• 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)

Locations
Other Locations
Canada
CancerCare Manitoba
RECRUITING
Winnipeg
Contact Information
Primary
Brett Houston, MD, PhD
bhouston@cancercare.mb.ca
204-787-8552
Backup
Nora Choi, MSc
nchoi@hsc.mb.ca
204-787-8552
Time Frame
Start Date: 2025-09-10
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 75
Treatments
Experimental: Tranexamic Acid
Placebo_comparator: Matching Placebo
Sponsors
Leads: University of Manitoba

This content was sourced from clinicaltrials.gov