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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborator: Alberta Cancer Foundation
• Treatments: Tranexamic Acid

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