TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia

NCT ID: NCT03136445

Last Updated: 2025-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 616 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2022-06-18

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.

Detailed Description

Patients with cancers of the blood often develop low blood cell counts either as a consequence of the disease or the treatment by chemotherapy or stem cell transplantation. Platelet transfusions are commonly given to raise any low platelet count and reduce the risk of clinical bleeding (prophylaxis) or stop active bleeding (therapy). But recent studies have indicated that many patients continue to experience bleeding, despite the use of platelet transfusions. Tranexamic acid is a type of drug that is called an antifibrinolytic. These drugs act to reduce the breakdown of clots formed in response to bleeding. These drugs have been used widely in both elective and emergency surgery and have been shown to decrease blood loss and the use of red cell transfusions. 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. The investigators will measure the rates of bleeding daily using a short structured assessment of bleeding and will record the number of transfusions given to patients.

Conditions

Hematologic Neoplasms; Hemorrhage; Hematopoietic Stem Cell Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Arm

Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO.

Group Type: EXPERIMENTAL

Tranexamic acid (TXA).

Intervention Type: DRUG

IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.

Control Arm

Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV (saline) or oral placebo tablets

Interventions

Tranexamic acid (TXA).

IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.

Intervention Type: DRUG

Placebo

IV (saline) or oral placebo tablets

Intervention Type: DRUG

Other Intervention Names

Cyklokapron®; trans-4-(aminomethyl)cyclohexanecarboxylic acid; Lysteda; Placebo for tranexamic acid

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health and Medical Research Council, Australia

OTHER

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: collaborator

NHS Blood and Transplant

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lise J Estcourt, MBBChir MSc DPhil MRCP FRCPath

Role: PRINCIPAL_INVESTIGATOR

NHS Blood and Transplant

Zoe K McQuilten, MBBS PhD

Role: PRINCIPAL_INVESTIGATOR

Monash University

Simon J Stanworth, DPhil FRCP FRCPath

Role: PRINCIPAL_INVESTIGATOR

NHS Blood and Transplant

Erica M Wood, MB BS, FRACP, FRCPA

Role: PRINCIPAL_INVESTIGATOR

Monash University

Locations

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

Countries

Australia; United Kingdom

References

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.

Reference Type: RESULT

PMID: 39642900 (View on PubMed)

Estcourt 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.

Reference Type: DERIVED

PMID: 31615553 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Study Documents

Document Type: Study Protocol

The protocol was published in The Trials Journal, 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 Free Article - Estcourt LJ, McQuilten Z, Powter G, Dyer C, Curnow E, Wood EM, Stanworth SJ, TREATT Trial Collaboration (provisional). To request a protocol please contact the Trial Manager Gillian Powter gillian.powter@nhsbt.nhs.uk

View Document

Related Links

https://doi.org/10.1016/S2352-3026(24)00317-X

Published paper- 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

Other Identifiers

2014-001513-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ISRCTN73545489

Identifier Type: REGISTRY

Identifier Source: secondary_id

12-01-CSU

Identifier Type: -

Identifier Source: org_study_id