Phase 3
N=616
TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia
Hematologic Neoplasms · Hemorrhage · Hematopoietic Stem Cell Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT03136445 ↗Enrolled (actual)
616
Serious AEs
26.6%
Results posted
Oct 2025
Primary outcome: Primary: The Proportion of Patients Who Die or Have Bleeding of WHO Grade 2 or Above by WHO Criteria During the First 30 Days From the First Dose of Trial Treatment, or Planned First Dose for Those Participants Who do Not Receive Treatment. — 31.7; 34.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tranexamic acid (TXA). (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NHS Blood and Transplant
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Patients Who Die or Have Bleeding of WHO Grade 2 or Above by WHO Criteria During the First 30 Days From the First Dose of Trial Treatment, or Planned First Dose for Those Participants Who do Not Receive Treatment. |
31.7; 34.2 | — |
| SECONDARY Mean (SD) Percentage of Days With WHO Grade 2 Bleeding or Above, Per Participant. |
3.1; 3.2 | — |
| SECONDARY Time to First Episode of Bleeding of WHO Grade 2 or Greater up to Study Day 30. |
NA; NA | — |
| SECONDARY Highest Grade of Bleeding a Patient Experiences up to Study Day 30. |
7; 6; 0; 1; 85; 93 | — |
| SECONDARY Number of Platelet Transfusions Per Patient up to Study Day 30. |
3; 3 | — |
| SECONDARY Number of Red Cell Transfusions Per Patient up to Study Day 30. |
2; 2 | — |
| SECONDARY Proportion of Patients Surviving at Least 30 Days Without a Platelet Transfusion. |
8.3; 6.4 | — |
| SECONDARY Proportion of Patients Surviving at Least 30 Days Without a Red Cell Transfusion. |
29.4; 20.5 | — |
| SECONDARY Number of Participants With a Thrombotic Event From First Administration of Trial Treatment up to and Including 120 Days After the First Dose of Trial Treatment is Received (N) |
8; 5 | — |
| SECONDARY Number of Patients Developing Veno-occlusive Disease (VOD; Sinusoidal Obstructive Syndrome, SOS) Within 60 Days of First Administration of Trial Treatment. |
3; 2 | — |
| SECONDARY All-cause Mortality During the First 30 Days and 120 Days After the First Dose of Trial Treatment is Administered. |
2.9; 1.1; 8.7; 5.3 | — |
| SECONDARY Death Due to Thrombosis During the First 120 Days After the First Dose of Trial Treatment is Administered. |
0; 0 | — |
| SECONDARY Death Due to Bleeding During the First 30 Days After the First Dose of Trial Treatment is Administered. |
0; 0 | — |
| SECONDARY Number of Serious Adverse Events (SAE) From First Administration of Trial Treatment Until 60 Days After the First Dose of Trial Treatment is Administered. |
94; 103; 25; 27; 4; 7 | — |
Summary
The purpose of this study is to test whether giving tranexamic acid to patients receiving treatment for blood cancers reduces the risk of bleeding or death, and the need for platelet transfusions. Patients will be randomised to receive tranexamic acid (given intravenously through a drip, or orally) or a placebo.
Eligibility Criteria
Inclusion Criteria
Patients are eligible for this trial if:
- Aged ≥18 years of age
- Confirmed diagnosis of a haematological malignancy
- Undergoing chemotherapy, or chemotherapy is planned, or haematopoietic stem cell transplantation
- Anticipated to have a hypoproliferative thrombocytopenia resulting in a platelet count of ≤10x10⁹/L for ≥ 5 days
- Able to comply with treatment and monitoring
Exclusion Criteria
A patient will not be eligible for this trial if he/she fulfils one or more of the following criteria:
- Patients with a past history or current diagnosis of arterial or venous thromboembolic disease including myocardial infarction, peripheral vascular disease and retinal arterial or venous thrombosis.
- Diagnosis of acute promyelocytic leukaemia (APML) and undergoing induction chemotherapy
- Patients with a diagnosis/previous history of veno-occlusive disease (also called sinusoidal obstruction syndrome)
- Patients with known inherited or acquired prothrombotic disorders e.g.
- Lupus anticoagulant
- Positive antiphospholipids
- Patients receiving any pro-coagulant agents (e.g. DDAVP, recombinant Factor VIIa or Prothrombin Complex Concentrates (PCC) within 48 hours of enrolment, or with known hypercoagulable state
- Patients receiving L-asparaginase as part of their current cycle of treatment
- History of immune thrombocytopenia (ITP), thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS)
- Patients with overt disseminated intravascular coagulation (DIC) (See Appendix 3 in the protocol for definition)
- Patients requiring a platelet transfusion threshold >10x10/⁹L at time of randomisation. (This refers to patients who require their platelet count to be maintained at a certain specified level on an ongoing basis, and excludes a transient rise in the threshold due to sepsis.)
- Patients with a known inherited or acquired bleeding disorder e.g.
- Acquired storage pool deficiency
- Paraproteinaemia with platelet inhibition
- Patients receiving anticoagulant therapy or anti-platelet therapy
- Patients with visible haematuria at time of randomisation
- Patients with anuria (defined as urine output < 10 mls/hr over 24 hours).
- Patients with severe renal impairment (eGFR ≤30 ml/min/1.73m²)
- Patients with a previous history of epilepsy, convulsions, fits or seizures
- Patients who are pregnant or breast-feeding
- Allergic to tranexamic acid.
- Patients enrolled in other trials involving platelet transfusions, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents.
- Patients previously randomised into this trial at any stage of their treatment.
Data sourced from ClinicalTrials.gov (NCT03136445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.