Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)
Hematologic NeoplasmsIt 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 platelet transfusions in patients undergoing an autologous hematopoietic stem cell transplantation (ASCT).
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation 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
Study Location
Eastern Regional Health Authority
Eastern Regional Health AuthoritySaint John's, Newfoundland and Labrador
Canada
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London Health Sciences Centre
London Health Sciences CentreLondon, Ontario
Canada
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Saskatchewan Cancer Agency
Saskatchewan Cancer AgencySaskatoon, Saskatchewan
Canada
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Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
Hamilton Health Sciences - Juravinski Hospital and Cancer CentreHamilton, Ontario
Canada
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Cross Cancer Institute
Cross Cancer InstituteEdmonton, Alberta
Canada
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Irwindeep Sandhu, MD
Hopital Maisonneuve-Rosemont
Hopital Maisonneuve-RosemontMontréal, Quebec
Canada
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Silvy Lachance, MD
Memorial University
Memorial UniversitySt. John's, Newfoundland and Labrador
Canada
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Kirsty Tompkins, MD
The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
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Dalhousie University
Dalhousie UniversityHalifax, Nova Scotia
Canada
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Mahmood El-Sawy, MD
Tom Baker Cancer Centre
Tom Baker Cancer CentreCalgary, Alberta
Canada
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Princess Margaret Cancer Centre
Princess Margaret Cancer CentreToronto, Ontario
Canada
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- Study Sponsored By
- Ottawa Hospital Research Institute
- Participants Required
- More Information
- Study ID:
NCT04448184