Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Jun 24, 2020

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ClinConnect Summary

The PATH III Trial is a clinical study looking at the best way to manage platelet transfusions for patients undergoing a specific type of treatment called autologous hematopoietic stem cell transplantation (ASCT), which is often used to treat blood cancers. The trial is testing whether a combination of a medication called Tranexamic Acid (TXA) taken by mouth and through an IV, along with platelet transfusions when needed, is safer and more effective compared to just giving platelet transfusions beforehand.

To participate in this trial, you need to be an adult aged 18 or older who is scheduled for ASCT due to a blood-related cancer and be able to provide informed consent. However, some individuals may not be eligible, such as those with recent serious bleeding events, certain blood clotting disorders, or those currently pregnant or breastfeeding. If you join the study, you will be closely monitored to ensure your safety and to see how well this approach works. This research aims to improve treatment for patients like you, helping to manage potential bleeding risks during the transplantation process.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Adults 18 years or older undergoing ASCT for a hematologic malignancy
• • 2. Patients providing written informed consent prior to starting transplantation
• Exclusion Criteria:
• • 1. A previous WHO grade 2, 3 or 4 bleeding event within the past year
• • 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