Status:
RECRUITING
Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Alberta Cancer Foundation
Conditions:
Hematologic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
It is hypothesized that a strategy using prophylactic oral and intravenous Tranexamic Acid (TXA) with therapeutic platelet transfusions (if required) is safe and more effective than prophylactic plate...
Detailed Description
In Canada, over 1,500 autologous hematopoietic stem cell transplantations (ASCT) are performed annually for hematologic malignancies. It is currently standard practice to provide a prophylactic transf...
Eligibility Criteria
Inclusion
- Adults 18 years or older undergoing ASCT for a hematologic malignancy
- Patients providing written informed consent prior to starting transplantation
Exclusion
- A previous WHO grade 2, 3 or 4 bleeding event within the past year
- A previous or current unprovoked thrombotic event defined as a pulmonary embolism, deep vein thrombosis, cerebral thrombosis
- A current provoked thrombotic event (e.g. catheter-related thrombosis) within last month and/or still requiring anticoagulant treatment.
- A requirement for therapeutic anticoagulant or anti-platelet drugs during ASCT
- Active angina (chest pain of presumed cardiac origin either at rest or with activity)
- Current or previous (within 2 weeks) urinary tract bleeding
- An inherited hemostatic or thrombotic disorder
- 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
- 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)
- 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)
- Pregnant or breast-feeding
- Unwilling or unable to provide informed consent
- Participant has acquired disturbances to his/her colour vision (does not apply to congenital colour blindness)
- Participant has known sensitivity or allergy to Tranexamic Acid or any of its ingredients
Key Trial Info
Start Date :
February 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
662 Patients enrolled
Trial Details
Trial ID
NCT04448184
Start Date
February 16 2022
End Date
February 1 2027
Last Update
January 8 2026
Active Locations (12)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N4N2
2
Cross Cancer Institute
Edmonton, Alberta, Canada
3
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
4
Memorial University
St. John's, Newfoundland and Labrador, Canada