Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)
PATH
1 other identifier
interventional
662
1 country
12
Brief Summary
It is hypothesized that a strategy using prophylactic oral and intravenous Tranexamic Acid (TXA) with therapeutic platelet transfusions (if required) is safe and more effective than prophylactic platelet transfusions in patients undergoing an autologous hematopoietic stem cell transplantation (ASCT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2022
Longer than P75 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedStudy Start
First participant enrolled
February 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
January 8, 2026
January 1, 2026
5 years
April 24, 2020
January 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
WHO (World Health Organization) bleeding events of Grade 2 or higher
Daily, up to 30 days
Secondary Outcomes (19)
WHO bleeding events of Grade 3 or 4
Daily, up to 30 days
Time from randomization to bleeding of WHO events Grade 2 or higher
Daily, up to 30 days
Number of days with bleeding of WHO bleeding events Grade 2 or higher
Daily, up to 30 days
Bleeding Severity Measurement Scale (BSMS) for bleeding events Grade 2 or higher
Daily, up to 30 days
Number of platelet and/or red blood cell transfusions
Daily, up to 30 days
- +14 more secondary outcomes
Study Arms (2)
Prophylactic Platelet Transfusion
NO INTERVENTIONPatients allocated to the prophylactic platelet transfusion group will receive a platelet transfusion when the measured platelet count is less than 10 x 109/L.
Prophylactic Tranexamic Acid
EXPERIMENTALPatients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral or intravenous dose of Tranexamic Acid 1 gram three times daily.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adults 18 years or older undergoing ASCT for a hematologic malignancy
- Patients providing written informed consent prior to starting transplantation
You may not qualify if:
- A previous WHO grade 2, 3 or 4 bleeding event within the past year
- A previous or current unprovoked thrombotic event defined as a pulmonary embolism, deep vein thrombosis, cerebral thrombosis
- A current provoked thrombotic event (e.g. catheter-related thrombosis) within last month and/or still requiring anticoagulant treatment.
- A requirement for therapeutic anticoagulant or anti-platelet drugs during ASCT
- Active angina (chest pain of presumed cardiac origin either at rest or with activity)
- Current or previous (within 2 weeks) urinary tract bleeding
- An inherited hemostatic or thrombotic disorder
- 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
- 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)
- 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)
- Pregnant or breast-feeding
- Unwilling or unable to provide informed consent
- Participant has acquired disturbances to his/her colour vision (does not apply to congenital colour blindness)
- Participant has known sensitivity or allergy to Tranexamic Acid or any of its ingredients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ottawa Hospital Research Institutelead
- Alberta Cancer Foundationcollaborator
Study Sites (12)
Tom Baker Cancer Centre
Calgary, Alberta, T2N4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador, A1B 3V6, 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, L8V 1C3, Canada
London Health Sciences Centre
London, Ontario, N6A5W9, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H8L6, Canada
Niagara Health System
St. Catharines, Ontario, L2S 0A9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Saskatchewan Cancer Agency
Saskatoon, Saskatchewan, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Tinmouth, MD
The Ottawa Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2020
First Posted
June 25, 2020
Study Start
February 16, 2022
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
January 8, 2026
Record last verified: 2026-01