It is hypothesized that a strategy using prophylactic oral Tranexamic Acid (TXA) with therapeutic platelet transfusions is safe and effective compared to prophylactic platelet transfusions in patients undergoing an autologous hematopoietic stem cell transplantation (who are at risk for bleeding).
In Canada, over 1,500 autologous hematopoietic stem cell transplantations (ASCT) are performed annually for hematologic malignancies. It is currently standard practice to provide a prophylactic transfusion of platelets to prevent bleeding when the daily measured platelet count is less than 10 x 109/L. A patient may require up to six adult platelet doses during the post-transplant period. However, the true benefit of prophylactic platelet transfusions in the ASCT setting is unclear and has been called into question by several recent studies. Prophylactic platelet transfusions may not only be unnecessary, they may be detrimental to the patient. Among blood products, platelet transfusions are associated with the highest risk of both infectious and non-infectious complications: this would include bacterial infections and allergic /febrile reactions. Moreover, the potential overuse of platelet products places a significant burden on a scarce health care resource that is provided through volunteer donations. An alternative strategy to prevent bleeding and reduce the need for platelet transfusions involves administering Tranexamic Acid, an oral antifibrinolytic agent to stabilize blood clots and reduce bleeding. Tranexamic Acid is safe and effective in many clinical scenarios, and may be a reasonable alternative for prophylactic platelet transfusions. In the setting of ASCT, Tranexamic Acid may reduce bleeding and further enhance a strategy of therapeutic platelet transfusions where platelets are administered only in the event of active bleeding symptoms. The effect of prophylactic platelet transfusions and Tranexamic Acid on clinical, quality of life and economic outcomes in patients receiving ASCT is unknown. The primary aim of this research program is to perform a randomized controlled trial to determine whether a strategy of prophylactic Tranexamic Acid (with therapeutic platelet transfusions) is safe and effective compared to prophylactic platelet transfusions in patients undergoing ASCT. Before conducting a larger trial, the investigators first propose a pilot randomized controlled trial to determine the feasibility of such a study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
100
Tom Baker Cancer Centre
Calgary, Alberta, 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
Enrolment, as measured by the number of patients screened per month at each site
Time frame: monthly, up to 23 months
Number of off-protocol platelet transfusions, with a target of < 10% off-protocol transfusions in each treatment arm
Time frame: monthly, up to 23 months
Total number of platelet transfusions/group, with a target of 25% reduction in the tranexamic acid arm
Time frame: monthly, up to 23 months
Adherence to tranexamic acid use, defined as excellent (greater than or equal to 90% use), acceptable (75-90% use), poor (< 75% use)
Time frame: monthly, up to 23 months
WHO (World Health Organization) Bleeding events of Grade 2 or higher
Time frame: daily, up to one month
Time from randomization to bleeding of WHO bleeding events Grade 2 or higher
Time frame: daily, up to one month
Number of days with bleeding of WHO bleeding events Grade 2 or higher
Time frame: daily, up to one month
Bleeding Severity Measurement Scale for bleeding events Grade 2 or higher
Time frame: daily, up to one month
Number of platelet and/or red cell transfusions
Time frame: daily, up to one month
Time to platelet recovery
Time frame: daily, up to one month
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Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Number of days with platelet count < 10 x 10^9/L
Time frame: daily, up to one month
LOS (Length of hospital stay)
LOS=discharge date - admission date
Time frame: Length of stay will be measured as the number of days elapsed between hospital admission and hospital discharge dates up to 1 month
Adverse transfusion reactions
Number and type of reactions will be recorded.
Time frame: daily, up to one month
Bearman Toxicity Score
Validated scoring system to assess toxicity during stem cell transplantation
Time frame: Day 30
Infections at Day 30
Time frame: Day 30
Quality of Life measurements, as determined by a battery of QoL instruments
Time frame: daily, up to one month