Can a cheap clot drug save lives in blood cancer patients?
NCT ID NCT03136445
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether tranexamic acid, a drug that helps blood clot, can lower the risk of serious bleeding or death in people with blood cancers who have dangerously low platelet counts. Over 600 adults receiving chemotherapy or a stem cell transplant were randomly given either the drug or a placebo. The goal was to see if the drug could reduce the need for platelet transfusions and improve outcomes during the first 30 days of treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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616 people
The number who actually took part.
- Started
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Jun 2015
- Finished
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Jun 2022
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients are eligible for this trial if: 1. Aged ≥18 years of age 2. Confirmed diagnosis of a haematological malignancy 3. Undergoing chemotherapy, or chemotherapy is planned, or haematopoietic stem cell transplantation 4. Anticipated to have a hypoproliferative thrombocytopenia resulting in a platelet count of ≤10x10⁹/L for ≥ 5 days 5. 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: 1. 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. 2. Diagnosis of acute promyelocytic leukaemia (APML) and undergoing induction chemotherapy 3. Patients with a diagnosis/previous history of veno-occlusive disease (also called sinusoidal obstruction syndrome) 4. Patients with known inherited or acquired prothrombotic disorders e.g. 1. Lupus anticoagulant 2. Positive antiphospholipids 5. 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 6. Patients receiving L-asparaginase as part of their current cycle of treatment 7. History of immune thrombocytopenia (ITP), thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS) 8. Patients with overt disseminated intravascular coagulation (DIC) (See Appendix 3 in the protocol for definition) 9. 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.) 10. Patients with a known inherited or acquired bleeding disorder e.g. 1. Acquired storage pool deficiency 2. Paraproteinaemia with platelet inhibition 11. Patients receiving anticoagulant therapy or anti-platelet therapy 12. Patients with visible haematuria at time of randomisation 13. Patients with anuria (defined as urine output \< 10 mls/hr over 24 hours). 14. Patients with severe renal impairment (eGFR ≤30 ml/min/1.73m²) 15. Patients with a previous history of epilepsy, convulsions, fits or seizures 16. Patients who are pregnant or breast-feeding 17. Allergic to tranexamic acid. 18. Patients enrolled in other trials involving platelet transfusions, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents. 19. Patients previously randomised into this trial at any stage of their treatment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alfred Hospital
Melbourne, Australia
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Andrew Love Cancer Centre
Geelong, Australia
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Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
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Belfast City Hospital
Belfast, United Kingdom
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Bristol Haematology and Oncology Centre
Bristol, United Kingdom
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Canberra Hospital
Canberra, Australia
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Churchill Hospital
Oxford, United Kingdom
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Derriford Hospital
Plymouth, United Kingdom
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Freeman Hospital
Newcastle, United Kingdom
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Heartlands Hospital
Birmingham, United Kingdom
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King's College Hospital
London, United Kingdom
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Lincoln County Hospital
Lincoln, United Kingdom
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Monash Health
Melbourne, Australia
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Queen Elizabeth Hospital
Birmingham, United Kingdom
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Royal Adelaide Hospital
Adelaide, Australia
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Royal Brisbane
Brisbane, Australia
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Royal Devon and Exeter Hospital
Exeter, United Kingdom
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Royal North Shore Hospital
St Leonards, Australia
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Royal United Hospital
Bath, United Kingdom
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Salisbury District Hospital
Salisbury, United Kingdom
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St James's Hospital
Leeds, United Kingdom
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St Vincent's Hospital
Melbourne, Australia
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St Vincent's Hospital
Sydney, Australia
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University College London Hospitals
London, United Kingdom
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University Hospital Coventry
Coventry, United Kingdom
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Victorian Comprehensive Cancer Centre
Melbourne, Australia
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Westmead Hospital
Westmead, Australia
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Other studies related to the condition(s) this trial covers.
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