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).
Adults 18 years or older undergoing ASCT for a hematologic malignancy
Patients providing written informed consent prior to starting transplantation
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
Parallel
Tranexamic Acid
DrugPatients 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.
WHO (World Health Organization) bleeding events of Grade 2 or higher
WHO bleeding events of Grade 3 or 4
Time from randomization to bleeding of WHO events Grade 2 or higher
Number of days with bleeding of WHO bleeding events Grade 2 or higher
Bleeding Severity Measurement Scale (BSMS) for bleeding events Grade 2 or higher
The BSMS scale measures bleeding grade and classification from 0-2. 0 indicates no bleeding. Grade 1 bleeding consists of trace bleeding and mild bleeding and is not clinically significant. Grade 2 bleeding consists of serious bleeding, serious bleeding causing significant morbidity, and fatal bleeding. Grade 2 bleeding is clinically significant.
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Ottawa Hospital Research Institute
Lead sponsor
Alberta Cancer Foundation
Collaborator
