Clinical trial · Interventional
Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)
Platelet Transfusions in Hematopoietic Stem Cell Transplantation - The PATH Phase III Trial
NCT04448184CI-TRIAL-00100475PATHrecruitingPhase 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 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).
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 Transfusion
- description
- Patients allocated to the prophylactic platelet transfusion group will receive a platelet transfusion when the measured platelet count is less than 10 x 109/L.
- type
- EXPERIMENTAL
- label
- Prophylactic Tranexamic Acid
- description
- 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.
- interventionNames
- Drug: Tranexamic Acid
Primary outcomes (1)
- measure
- WHO (World Health Organization) bleeding events of Grade 2 or higher
- timeFrame
- Daily, up to 30 days
Secondary outcomes (19)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.