Using Tranexamic Acid to Reduce Platelet Transfusions in Stem Cell Transplant Patients

Platelet Transfusions in Hematopoietic Stem Cell Transplantation - The PATH Phase III Trial

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: PHASE3
• Study type: Interventional
• Enrollment: 662 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (other)
• Locations: 12 sites (Calgary, Alberta and 11 other locations)
• Trial ID: NCT04448184 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are undergoing ASCT for a hematologic malignancy.

Not a fit: Patients with a history of significant bleeding events or thrombotic events may not benefit from this 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 performed: Previous studies have raised questions about the necessity of prophylactic platelet transfusions, suggesting that this approach may be a novel and untested strategy.

Eligibility 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 this trial is running

Calgary, Alberta and 11 other locations

• 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)
• Memorial University — St. John's, Newfoundland and Labrador, Canada (NOT_YET_RECRUITING)
• Dalhousie University — Halifax, Nova Scotia, Canada (NOT_YET_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)
• Niagara Health System — St. Catharines, Ontario, Canada (RECRUITING)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (WITHDRAWN)
• Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada (NOT_YET_RECRUITING)
• Saskatchewan Cancer Agency — Saskatoon, Saskatchewan, Canada (RECRUITING)

Study contacts

• Principal investigator: Alan Tinmouth, MD — The Ottawa Hospital
• Study coordinator: Sohail Robert, RN

Conditions: Hematologic Neoplasms