Clinical trial · Interventional
Platelet Transfusion Requirements in Hematopoietic Transplantation Pilot Study
Platelet Transfusion Requirements in Hematopoietic Transplantation(PATH Pilot)
NCT02650791CI-TRIAL-00045131PATHcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tranexamic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Prophylactic Platelet Transfusions
- description
- Patients allocated to the prophylactic platelet transfusion group will receive a platelet transfusion when the measured platelet count is less than 10 x 10\^9/L.
- type
- EXPERIMENTAL
- label
- Prophylactic Tranexamic Acid
- description
- Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral dose of Tranexamic Acid 1 gram three times daily. Tranexamic Acid will start when Platelet count is less than 50 x 10\^9/L and continue until platelet engraftment. Patients in this group will not receive routine prophylactic platelet transfusions
- interventionNames
- Drug: Tranexamic Acid
Primary outcomes (4)
- measure
- Enrolment, as measured by the number of patients screened per month at each site
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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 .
References
Publications (1)
- DERIVEDTay J, Allan D, Beattie S, Bredeson C, Fergusson D, Maze D, Sabloff M, Thavorn K, Tinmouth A. Rationale and design of platelet transfusions in haematopoietic stem cell transplantation: the PATH pilot study. BMJ Open. 2016 Oct 24;6(10):e013483. doi: 10.1136/bmjopen-2016-013483. PMID 27798034