TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia (NCT03136445) | Clinical Trial Compass
CompletedPhase 3
TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia
Australia616 participantsStarted 2015-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✕. 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
What they're measuring
1
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.
Timeframe: The first 30 days from first dose of trial treatment