Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)
NCT ID: NCT04448184
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
662 participants
INTERVENTIONAL
2022-02-16
2027-02-28
Brief Summary
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Detailed Description
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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 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.
A pilot trial demonstrated feasibility by successfully recruiting 100 patients and these patients will be rolled over into the phase III study. The treatment assignment and bleeding outcomes for these patients remain blinded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Prophylactic Platelet Transfusion
Patients allocated to the prophylactic platelet transfusion group will receive a platelet transfusion when the measured platelet count is less than 10 x 109/L.
No interventions assigned to this group
Prophylactic Tranexamic Acid
Patients 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
Patients 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.
Interventions
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Tranexamic Acid
Patients 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients providing written informed consent prior to starting transplantation
Exclusion Criteria
2. A previous or current unprovoked thrombotic event defined as a pulmonary embolism, deep vein thrombosis, cerebral thrombosis
3. A current provoked thrombotic event (e.g. catheter-related thrombosis) within last month and/or still requiring anticoagulant treatment.
4. A requirement for therapeutic anticoagulant or anti-platelet drugs during ASCT
5. Active angina (chest pain of presumed cardiac origin either at rest or with activity)
6. Current or previous (within 2 weeks) urinary tract bleeding
7. An inherited hemostatic or thrombotic disorder
8. Coagulopathy defined as a prothrombin time '/International Normalization Ratio (INR) or activated partial thromboplastin time more than 1.5 times the upper limit of normal or fibrinogen less than 2 g/L
9. Previously documented history of refractoriness to platelet transfusion secondary to HLA antibodies (Refractoriness is defined as 2 consecutive ABO matched platelet transfusions with platelet increment of \< 7.5 and the presence of anti-HLA antibodies)
10. Significant renal impairment (creatinine more than 1.5 times the upper limit of normal or a eGFR less than 0.5 mL/min/1.78m2)
11. Pregnant or breast-feeding
12. Unwilling or unable to provide informed consent
13. Participant has acquired disturbances to his/her colour vision (does not apply to congenital colour blindness)
14. Participant has known sensitivity or allergy to Tranexamic Acid or any of its ingredients
18 Years
ALL
No
Sponsors
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Ottawa Hospital Research Institute
OTHER
Alberta Cancer Foundation
OTHER
Responsible Party
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Principal Investigators
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Alan Tinmouth, MD
Role: PRINCIPAL_INVESTIGATOR
The Ottawa Hospital
Locations
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Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador, Canada
Memorial University
St. John's, Newfoundland and Labrador, Canada
Dalhousie University
Halifax, Nova Scotia, 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
Niagara Health System
St. Catharines, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Saskatchewan Cancer Agency
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Irwindeep Sandhu, MD
Role: primary
Role: backup
Kirsty Tompkins, MD
Role: primary
Mahmood El-Sawy, MD
Role: primary
Kylie Lepic, MD
Role: primary
Silvy Lachance, MD
Role: primary
Other Identifiers
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2068
Identifier Type: -
Identifier Source: org_study_id
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