TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia
TREATT
A Double-blind, Randomised Controlled Trial Evaluating the Safety and Efficacy of Antifibrinolytics (Tranexamic Acid) in Patients With Haematological Malignancies With Severe Thrombocytopenia
3 other identifiers
interventional
616
2 countries
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2015
Longer than P75 for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 21, 2017
CompletedFirst Posted
Study publicly available on registry
May 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2022
CompletedResults Posted
Study results publicly available
October 28, 2025
CompletedOctober 28, 2025
September 1, 2025
6.7 years
February 21, 2017
June 23, 2025
September 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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. A time-to-event analysis will be used to determine this proportion to ensure that all patients are included in the primary outcome analysis, not just those who are followed up for the full 30 days. Any patients lost to follow-up will be included in the analysis and censored at the time that they were lost.
The first 30 days from first dose of trial treatment
Secondary Outcomes (13)
Mean (SD) Percentage of Days With WHO Grade 2 Bleeding or Above, Per Participant.
The first 30 days from first dose of trial treatment .
Time to First Episode of Bleeding of WHO Grade 2 or Greater up to Study Day 30.
The first 30 days from first dose of trial treatment.
Highest Grade of Bleeding a Patient Experiences up to Study Day 30.
The first 30 days from first dose of trial treatment.
Number of Platelet Transfusions Per Patient up to Study Day 30.
The first 30 days from first dose of trial treatment.
Number of Red Cell Transfusions Per Patient up to Study Day 30.
The first 30 days from first dose of trial treatment.
- +8 more secondary outcomes
Other Outcomes (4)
Proportion of Days With Thrombocytopenia (≤10x10⁹/L, ≤30x10⁹L, ≤50x10⁹/L).
Measured during first 30 days from first dose of IMP.
Reasons for Platelet Transfusions.
Measured during first 30 days from first dose of IMP.
Reasons for Red Cell Transfusions.
Measured during first 30 days from first dose of IMP.
- +1 more other outcomes
Study Arms (2)
Intervention Arm
EXPERIMENTALTranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO.
Control Arm
PLACEBO COMPARATORPlacebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral.
Interventions
IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Blood and Transplantlead
- National Health and Medical Research Council, Australiacollaborator
- Monash Universitycollaborator
Study Sites (27)
Royal Adelaide Hospital
Adelaide, Australia
Royal Brisbane
Brisbane, Australia
Canberra Hospital
Canberra, Australia
Andrew Love Cancer Centre
Geelong, Australia
Alfred Hospital
Melbourne, Australia
Monash Health
Melbourne, Australia
St Vincent's Hospital
Melbourne, Australia
Victorian Comprehensive Cancer Centre
Melbourne, Australia
Royal North Shore Hospital
St Leonards, Australia
St Vincent's Hospital
Sydney, Australia
Westmead Hospital
Westmead, Australia
Royal United Hospital
Bath, United Kingdom
Belfast City Hospital
Belfast, United Kingdom
Heartlands Hospital
Birmingham, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
St James's Hospital
Leeds, United Kingdom
Lincoln County Hospital
Lincoln, United Kingdom
King's College Hospital
London, United Kingdom
University College London Hospitals
London, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
Related Publications (2)
TREATT Trial Investigators. Tranexamic acid versus placebo to prevent bleeding in patients with haematological malignancies and severe thrombocytopenia (TREATT): a randomised, double-blind, parallel, phase 3 superiority trial. Lancet Haematol. 2025 Jan;12(1):e14-e22. doi: 10.1016/S2352-3026(24)00317-X. Epub 2024 Dec 3.
PMID: 39642900RESULTEstcourt LJ, McQuilten Z, Powter G, Dyer C, Curnow E, Wood EM, Stanworth SJ; TREATT Trial Collaboration (provisional). The TREATT Trial (TRial to EvaluAte Tranexamic acid therapy in Thrombocytopenia): safety and efficacy of tranexamic acid in patients with haematological malignancies with severe thrombocytopenia: study protocol for a double-blind randomised controlled trial. Trials. 2019 Oct 15;20(1):592. doi: 10.1186/s13063-019-3663-2.
PMID: 31615553DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- A/Prof Lise Estcourt
- Organization
- NHS Blood and Transplant
Study Officials
- PRINCIPAL INVESTIGATOR
Lise J Estcourt, MBBChir MSc DPhil MRCP FRCPath
NHS Blood and Transplant
- PRINCIPAL INVESTIGATOR
Zoe K McQuilten, MBBS PhD
Monash University
- PRINCIPAL INVESTIGATOR
Simon J Stanworth, DPhil FRCP FRCPath
NHS Blood and Transplant
- PRINCIPAL INVESTIGATOR
Erica M Wood, MB BS, FRACP, FRCPA
Monash University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2017
First Posted
May 2, 2017
Study Start
June 1, 2015
Primary Completion
February 18, 2022
Study Completion
June 18, 2022
Last Updated
October 28, 2025
Results First Posted
October 28, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 9 months after publication and ending 5 years following article publication.
- Access Criteria
- Data will be shared with investigators whose use of the data has been assessed and approved by an NHSBT review committee as a methodologically sound proposal.
The datasets generated during and/or analysed during the current study will be available upon request from the NHSBT Clinical Trials Unit after de-identification (text, tables, figures and appendices) 9 months after publication and ending 5 years following article publication.