A Phase 3 interventional study of Tranexamic Acid in Hematologic Neoplasms, sponsored by Ottawa Hospital Research Institute. Completed at 5 sites in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-05-18.
Sponsored by Ottawa Hospital Research Institute · Phase 3, Interventional, and Other
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.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 100 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients allocated to the prophylactic platelet transfusion group will receive a platelet transfusion when the measured platelet count is less than 10 x 10\^9/L.
Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral dose of Tranexamic Acid 1 gram three times daily. Tranexamic Acid will start when Platelet count is less than 50 x 10\^9/L and continue until platelet engraftment. Patients in this group will not receive routine prophylactic platelet transfusions
Drug: Tranexamic Acid
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
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
Plan to share: No
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ottawa Hospital Research Institute