Hematologic Neoplasms Clinical Trial
Official title:
Platelet Transfusion Requirements in Hematopoietic Transplantation(PATH Pilot)
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.
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