Using Tranexamic Acid to Reduce Platelet Transfusions in Stem Cell Transplant Patients
Official title: Platelet Transfusions in Hematopoietic Stem Cell Transplantation - The PATH Phase III Trial
Run by Ottawa Hospital Research Institute · NCT04448184 · Data updated 2026-11-12
This study is testing if giving Tranexamic Acid along with platelet transfusions can help stem cell transplant patients need fewer transfusions and stay safer during their treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 662 (estimated) |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 12 sites (Calgary, Alberta and 11 other locations) |
| Status | Recruiting |
| Started | February 16, 2022 |
| Main results expected | February 2027 |
| Study ends | February 2027 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT04448184 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are undergoing ASCT for a hematologic malignancy.
✕Probably not a fit
Patients with a history of significant bleeding events or thrombotic events may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of using prophylactic oral and intravenous Tranexamic Acid (TXA) combined with therapeutic platelet transfusions in patients undergoing autologous hematopoietic stem cell transplantation (ASCT) for hematologic malignancies. The study aims to determine if this approach is safer and more effective than the standard practice of prophylactic platelet transfusions. By potentially reducing the need for platelet transfusions, the trial seeks to minimize the associated risks and complications while optimizing patient care. Participants will be monitored for bleeding events and platelet counts throughout the study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective management of bleeding in patients undergoing stem cell transplantation.
How similar studies have gone: Previous studies have raised questions about the necessity of prophylactic platelet transfusions, suggesting that this approach may be a novel and untested strategy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults 18 years or older undergoing ASCT for a hematologic malignancy 2. Patients providing written informed consent prior to starting transplantation Exclusion Criteria: 1. A previous WHO grade 2, 3 or 4 bleeding event within the past year 2. A previous or current unprovoked thrombotic event defined as a pulmonary embolism, deep vein thrombosis, cerebral thrombosis 3. A current provoked thrombotic event (e.g. catheter-related thrombosis) within last month and/or still requiring anticoagulant treatment. 4. A requirement for therapeutic anticoagulant or anti-platelet drugs during ASCT 5. Active angina (chest pain of presumed cardiac origin either at rest or with activity) 6. Current or previous (within 2 weeks) urinary tract bleeding 7. An inherited hemostatic or thrombotic disorder 8. Coagulopathy defined as a prothrombin time '/International Normalization Ratio (INR) or activated partial thromboplastin time more than 1.5 times the upper limit of normal or fibrinogen less than 2 g/L 9. Previously documented history of refractoriness to platelet transfusion secondary to HLA antibodies (Refractoriness is defined as 2 consecutive ABO matched platelet transfusions with platelet increment of \< 7.5 and the presence of anti-HLA antibodies) 10. Significant renal impairment (creatinine more than 1.5 times the upper limit of normal or a eGFR less than 0.5 mL/min/1.78m2) 11. Pregnant or breast-feeding 12. Unwilling or unable to provide informed consent 13. Participant has acquired disturbances to his/her colour vision (does not apply to congenital colour blindness) 14. Participant has known sensitivity or allergy to Tranexamic Acid or any of its ingredients
Where it's running
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Tom Baker Cancer Centre
Calgary, Alberta, Canada Recruiting -
Cross Cancer Institute
Edmonton, Alberta, Canada Recruiting -
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador, Canada Recruiting -
Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada Recruiting -
London Health Sciences Centre
London, Ontario, Canada Recruiting -
The Ottawa Hospital
Ottawa, Ontario, Canada Recruiting
Show 6 more locations
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Niagara Health System
St. Catharines, Ontario, Canada Recruiting -
Saskatchewan Cancer Agency
Saskatoon, Saskatchewan, Canada Recruiting -
Memorial University
St. John's, Newfoundland and Labrador, Canada Not yet recruiting -
Dalhousie University
Halifax, Nova Scotia, Canada Not yet recruiting -
Princess Margaret Cancer Centre
Toronto, Ontario, Canada Withdrawn -
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada Not yet recruiting
Study contacts
- Principal investigator: Alan Tinmouth, MD — The Ottawa Hospital
- Study coordinator: Sohail Robert, RN
- Email: sorobert@ohri.ca
- Phone: 613-737-8899
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.