Platelet Transfusion Requirements in Hematopoietic Transplantation Pilot Study

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

It is hypothesized that a strategy using prophylactic oral Tranexamic Acid (TXA) with therapeutic platelet transfusions is safe and effective compared to prophylactic platelet transfusions in patients undergoing an autologous hematopoietic stem cell transplantation (who are at risk for bleeding).

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

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

1. Patients are aged 18 years old or older and undergoing an autologous HSCT (hematopoietic stem cell transplantation) for any hematologic malignancy.

Exclusion Criteria:

1. A previous WHO grade 3 or 4 bleeding event

2. A WHO grade 2 bleeding event within the past year

3. A previous or current unprovoked thrombotic event defined as a pulmonary embolism, deep vein thrombosis, cerebral thrombosis

4. Current or previous (within 2 weeks) urinary tract bleeding

5. An inherited hemostatic or thrombotic disorder

6. Coagulopathy defined as a prothrombin time or activated partial thromboplastin time >1.5 times the upper limit of normal or fibrinogen less than 2 g/L

7. A requirement for therapeutic anticoagulant or antiplatelet drugs

8. Previously documented history of refractoriness to platelet transfusion secondary to HLA (Human Leukocyte Antigen) antibodies

9. Significant renal impairment (creatinine >1.5 times the upper limit of normal)

10. Pregnant or breast-feeding

11. Unwilling or unable to provide informed consent

12. Participant has ever had a pulmonary embolism, deep vein thrombosis, cerebral thrombosis or has active angina

13. Participant has known history of subarachnoid hemorrhage

14. Participant has acquired disturbances to his/her colour vision

15. Participant has known sensitivity or allergy to Tranexamic Acid or any of its ingredients

16. The current use of oral contraceptive pill (Birth Control Pill), hormonal contraceptives or hormone replacement therapy .