Platelet Transfusion Requirements in Hematopoietic Transplantation Pilot Study (PATH)
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|ClinicalTrials.gov Identifier: NCT02650791|
Recruitment Status : Completed
First Posted : January 8, 2016
Last Update Posted : May 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Neoplasms||Drug: Tranexamic Acid||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Platelet Transfusion Requirements in Hematopoietic Transplantation(PATH Pilot)|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||June 2019|
|Actual Study Completion Date :||December 2019|
No Intervention: Prophylactic Platelet Transfusions
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.
Experimental: Prophylactic Tranexamic Acid
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) [ 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 ]LOS=discharge date - admission date
- Adverse transfusion reactions [ Time Frame: daily, up to one month ]Number and type of reactions will be recorded.
- Bearman Toxicity Score [ Time Frame: Day 30 ]Validated scoring system to assess toxicity during stem cell transplantation
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650791
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N4N2|
|Hamilton Health Sciences - Juravinski Hospital and Cancer Centre|
|Hamilton, Ontario, Canada, L8V 1C3|
|London Health Sciences Centre|
|London, Ontario, Canada, N6A5W9|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Alan Tinmouth, MD MSc||Ottawa Hospital Research Institute|