RecruitingPhase 3NCT04448184

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

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


Sponsor

Ottawa Hospital Research Institute

Enrollment

662 participants

Start Date

Feb 16, 2022

Study Type

INTERVENTIONAL

Conditions

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 platelet transfusions in patients undergoing an autologous hematopoietic stem cell transplantation (ASCT).


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Adults 18 years or older undergoing ASCT for a hematologic malignancy
  • Patients providing written informed consent prior to starting transplantation

Exclusion Criteria14

  • 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

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Interventions

DRUGTranexamic Acid

Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral or intravenous dose of Tranexamic Acid 1 gram three times daily. Tranexamic Acid will start when Platelet count is less than 50 x 109/L and continue until platelet engraftment. Patients in this group will not receive routine prophylactic platelet transfusions. Subjects unable to swallow oral Tranexamic Acid pills may have the tablets crushed, administered via nasogastric (NG) tube or the medication will be administered intravenously.


Locations(12)

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Eastern Regional Health Authority

St. John's, Newfoundland and Labrador, Canada

Memorial University

St. John's, Newfoundland and Labrador, Canada

Dalhousie University

Halifax, Nova Scotia, Canada

Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Niagara Health System

St. Catharines, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Saskatchewan Cancer Agency

Saskatoon, Saskatchewan, Canada

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NCT04448184


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