RecruitingPhase 3

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

Canada662 participantsStarted 2022-02-16

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. 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

What they're measuring

WHO (World Health Organization) bleeding events of Grade 2 or higher

Timeframe: Daily, up to 30 days

Trial details

NCT IDNCT04448184

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Sohail Robert, RN

613-737-8899 sorobert@ohri.ca

View on ClinicalTrials.gov More Hematologic Neoplasms trials