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Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)

Hematologic Neoplasms

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 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 Authority
Saint John's, Newfoundland and Labrador
Canada

Contact Study Team

Primary Contact

David Jones, MD

[email protected]
London Health Sciences Centre
London Health Sciences Centre
London, Ontario
Canada

Contact Study Team

Primary Contact

Anargyros Xenocostas, MD

[email protected]
519-685-8500
Saskatchewan Cancer Agency
Saskatchewan Cancer Agency
Saskatoon, Saskatchewan
Canada

Contact Study Team

Primary Contact

Mohamed Elementary, MD

[email protected]
Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Irwin Walker, MD

[email protected]
905 521-2100
Cross Cancer Institute
Cross Cancer Institute
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Irwindeep Sandhu, MD

Hopital Maisonneuve-Rosemont
Hopital Maisonneuve-Rosemont
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Silvy Lachance, MD

Memorial University
Memorial University
St. John's, Newfoundland and Labrador
Canada

Contact Study Team

Primary Contact

Kirsty Tompkins, MD

The Ottawa Hospital
The Ottawa Hospital
Ottawa, Ontario
Canada

Contact Study Team

Primary Contact

Alan Tinmouth, MD

[email protected]
613-737-8899
Dalhousie University
Dalhousie University
Halifax, Nova Scotia
Canada

Contact Study Team

Primary Contact

Mahmood El-Sawy, MD

Tom Baker Cancer Centre
Tom Baker Cancer Centre
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Jason Tay, MD

[email protected]
403-944-1880
Princess Margaret Cancer Centre
Princess Margaret Cancer Centre
Toronto, Ontario
Canada

Contact Study Team

Study Sponsored By
Ottawa Hospital Research Institute
Participants Required
More Information
Study ID: NCT04448184