Clinical trial Recruiting at 8 sites Phase 3 Interventional Ages 18 and up

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

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment662 (estimated)
SponsorOttawa Hospital Research Institute
Academic / other
Locations12 sites (Calgary, Alberta and 11 other locations)
StatusRecruiting
StartedFebruary 16, 2022
Main results expectedFebruary 2027
Study endsFebruary 2027
Registry record updatedJanuary 8, 2026
Trial IDNCT04448184 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Anti-CD25 antibody to prevent acute GVHD after haploidentical stem cell transplant

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  • JNJ-95804306 in relapsed or refractory blood cancers

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  • Flu vaccine strategies for adults with blood cancers

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  • Combining donor-derived anti-CD19 CAR-T cells with haploidentical transplant using post-transplant cyclophosphamide

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.