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

Recruiting now · Phase 3

Conditions studied: Hematologic Neoplasms

In brief

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).

Key facts

Study ID

NCT04448184

Run by

Ottawa Hospital Research Institute

People needed

662

Starts

2022-02-16

Expected to finish

2027-02-01

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Saskatchewan Cancer Agency — Saskatoon, Saskatchewan, Canada (enrolling)
• Cross Cancer Institute — Edmonton, Alberta, Canada (enrolling)
• Eastern Regional Health Authority — St. John's, Newfoundland and Labrador, Canada (enrolling)
• London Health Sciences Centre — London, Ontario, Canada (enrolling)
• The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
• Niagara Health System — St. Catharines, Ontario, Canada (enrolling)
• Tom Baker Cancer Centre — Calgary, Alberta, Canada (enrolling)
• Hamilton Health Sciences - Juravinski Hospital and Cancer Centre — Hamilton, Ontario, Canada (enrolling)
• Memorial University — St. John's, Newfoundland and Labrador, Canada
• Dalhousie University — Halifax, Nova Scotia, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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