Using Tranexamic Acid to Prevent Bleeding in Blood Cancer Patients
Evaluation of Tranexamic Acid Among Outpatients With Myelodysplastic Syndromes and Acute Myeloid Leukemia: a Multicenter Pilot Trial
PHASE2 · University of Manitoba · NCT06599762
This study is testing if tranexamic acid can help prevent bleeding in patients with blood cancers like myelodysplastic syndromes and acute myeloid leukemia.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Manitoba (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Winnipeg, Manitoba) |
| Trial ID | NCT06599762 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of tranexamic acid (TXA) in preventing bleeding complications in patients with myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). It is a multicenter, randomized controlled trial where participants will be divided into two groups: one receiving TXA and the other receiving a placebo. The study aims to assess whether TXA can reduce the frequency and severity of bleeding in these patients, who often experience severe thrombocytopenia. The trial will monitor patient outcomes in an outpatient setting, focusing on the feasibility of patient enrollment and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with MDS or AML who are undergoing less-intensive chemotherapy and have severe thrombocytopenia.
Not a fit: Patients with known allergies to tranexamic acid or those with active thromboembolic disease or severe kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with MDS and AML by reducing bleeding complications.
How similar studies have performed: While TXA is commonly used in other clinical settings, this specific application in MDS and AML is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Winnipeg, Manitoba
- CancerCare Manitoba — Winnipeg, Manitoba, Canada (RECRUITING)
Study contacts
- Study coordinator: Brett Houston, MD, PhD
- Email: bhouston@cancercare.mb.ca
- Phone: 204-787-8552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Tranexamic Acid, Randomized Controlled Trial, Myelodysplastic Syndrome, Thrombocytopenia, myelodysplastic/myeloproliferative neoplasm