TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia (TREATT)

September 30, 2025 updated by: NHS Blood and Transplant

A Double-blind, Randomised Controlled Trial Evaluating the Safety and Efficacy of Antifibrinolytics (Tranexamic Acid) in Patients With Haematological Malignancies With Severe Thrombocytopenia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
616

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Royal Adelaide Hospital
      • Brisbane, Australia
        • Royal Brisbane
      • Canberra, Australia
        • Canberra Hospital
      • Geelong, Australia
        • Andrew Love Cancer Centre
      • Melbourne, Australia
        • Alfred Hospital
      • Melbourne, Australia
        • Monash Health
      • Melbourne, Australia
        • St Vincent's Hospital
      • Melbourne, Australia
        • Victorian Comprehensive Cancer Centre
      • St Leonards, Australia
        • Royal North Shore Hospital
      • Sydney, Australia
        • St Vincent's Hospital
      • Westmead, Australia
        • Westmead Hospital
  • United Kingdom
      • Bath, United Kingdom
        • Royal United Hospital
      • Belfast, United Kingdom
        • Belfast City Hospital
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital
      • Birmingham, United Kingdom
        • Heartlands Hospital
      • Bristol, United Kingdom
        • Bristol Haematology and Oncology Centre
      • Coventry, United Kingdom
        • University Hospital Coventry
      • Exeter, United Kingdom
        • Royal Devon and Exeter Hospital
      • Glasgow, United Kingdom
        • Beatson West of Scotland Cancer Centre
      • Leeds, United Kingdom
        • St James's Hospital
      • Lincoln, United Kingdom
        • Lincoln County Hospital
      • London, United Kingdom
        • King's College Hospital
      • London, United Kingdom
        • University College London Hospitals
      • Newcastle, United Kingdom
        • Freeman Hospital
      • Oxford, United Kingdom
        • Churchill Hospital
      • Plymouth, United Kingdom
        • Derriford Hospital
      • Salisbury, United Kingdom
        • Salisbury District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Arm
Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO.
Drug: Tranexamic acid (TXA).
IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.
Other Names:
  • Lysteda
  • Cyklokapron®
  • trans-4-(aminomethyl)cyclohexanecarboxylic acid
Placebo Comparator: Control Arm
Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral.
Drug: Placebo
IV (saline) or oral placebo tablets
Other Names:
  • Placebo for tranexamic acid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: The first 30 days from first dose of trial 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean (SD) Percentage of Days With WHO Grade 2 Bleeding or Above, Per Participant.
Time Frame: The first 30 days from first dose of trial treatment .
Number of days where WHO grade 2 or above bleeding has been recorded bleeding using WHO bleeding criteria.
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.
Time Frame: The first 30 days from first dose of trial treatment.
Bleeding assessed using WHO bleeding criteria. Time to first episode of bleeding of WHO grade 2 or above was estimated using a cumulative incidence function, with death as a competing risk. The lower quartile for the time is reported as the median was not estimable.
The first 30 days from first dose of trial treatment.
Highest Grade of Bleeding a Patient Experiences up to Study Day 30.
Time Frame: The first 30 days from first dose of trial treatment.

Measured using WHO bleeding criteria (The higher the grade, the most severe the bleed).

Grade 0: no bleeding Grade 1: petechial bleeding Grade 2: mild blood loss (clinically significant) Grade 3: gross blood loss, requires transfusion(severe) Grade 4: debilitating blood loss, retinal or cerebral associated with fatality
The first 30 days from first dose of trial treatment.
Number of Platelet Transfusions Per Patient up to Study Day 30.
Time Frame: The first 30 days from first dose of trial treatment.
Measured by number of recorded platelet transfusions per patient.
The first 30 days from first dose of trial treatment.
Number of Red Cell Transfusions Per Patient up to Study Day 30.
Time Frame: The first 30 days from first dose of trial treatment.
Measured by number of recorded red cell transfusions per patient.
The first 30 days from first dose of trial treatment.
Proportion of Patients Surviving at Least 30 Days Without a Platelet Transfusion.
Time Frame: The first 30 days from first dose of trial treatment.
Measured by calculating number of patients surviving at least 30 days without a platelet transfusion.
The first 30 days from first dose of trial treatment.
Proportion of Patients Surviving at Least 30 Days Without a Red Cell Transfusion.
Time Frame: The first 30 days from first dose of trial treatment.
Measured by calculating the number of patients surviving at least 30 days without a red cell transfusion.
The first 30 days from first dose of trial treatment.
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)
Time Frame: Up to and including 120 days from the first administration of investigational medicinal product (IMP).
Measured by calculating number of patients developing clinically diagnosed thrombotic events within 120 days of Treatment Day 1 i.e the first day that the IMP is administered.
Up to and including 120 days from the first administration of investigational medicinal product (IMP).
Number of Patients Developing Veno-occlusive Disease (VOD; Sinusoidal Obstructive Syndrome, SOS) Within 60 Days of First Administration of Trial Treatment.
Time Frame: Up to and including 60 days from the first administration of IMP.
Measured by calculating number of patients developing Veno-occlusive Disease (VOD; Sinusoidal obstructive syndrome, SOS) within 60 days of Treatment Day 1 i.e the first day that the IMP is administered.
Up to and including 60 days from the first administration of IMP.
All-cause Mortality During the First 30 Days and 120 Days After the First Dose of Trial Treatment is Administered.
Time Frame: Up to and including 120 days from the first administration of IMP.
Measured by calculating number of deaths in first 30 days and 120 days after Treatment Day 1 i.e the first day that the IMP is administered.
Up to and including 120 days from the first administration of IMP.
Death Due to Thrombosis During the First 120 Days After the First Dose of Trial Treatment is Administered.
Time Frame: Up to and including 120 days from the first administration of IMP.
Measured by calculating number of deaths due to thrombosis during the first 120 days after Treatment Day 1 i.e the first day that the IMP is administered.
Up to and including 120 days from the first administration of IMP.
Death Due to Bleeding During the First 30 Days After the First Dose of Trial Treatment is Administered.
Time Frame: Up to and including 30 days from the first administration of IMP.
Measured by calculating number of deaths due to bleeding during the first 30 days
Up to and including 30 days from the first administration of IMP.
Number of Serious Adverse Events (SAE) From First Administration of Trial Treatment Until 60 Days After the First Dose of Trial Treatment is Administered.
Time Frame: Up to and including 60 days from the first administration of IMP.
Measured by calculating the total number of SAE's reported from first administration of IMP.
Up to and including 60 days from the first administration of IMP.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Days With Thrombocytopenia (≤10x10⁹/L, ≤30x10⁹L, ≤50x10⁹/L).
Time Frame: Measured during first 30 days from first dose of IMP.
Measured by number of days that the patient's laboratory results indicate that the patient is thrombocytopenic.
Measured during first 30 days from first dose of IMP.
Reasons for Platelet Transfusions.
Time Frame: Measured during first 30 days from first dose of IMP.
Reasons for platelet transfusions as documented by clinician.
Measured during first 30 days from first dose of IMP.
Reasons for Red Cell Transfusions.
Time Frame: Measured during first 30 days from first dose of IMP.
Reasons for red cell transfusions as documented by clinician.
Measured during first 30 days from first dose of IMP.
Proportion of Days With Fever
Time Frame: Measured during first 30 days from first dose of IMP.
Highest daily temperature ≥ 38.1°C
Measured during first 30 days from first dose of IMP.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NHS Blood and Transplant

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Health and Medical Research Council, Australia
Monash University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12-01-CSU
  • 2014-001513-35 (EudraCT Number)
  • ISRCTN73545489 (Registry Identifier: ISRCTN Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

9 months after publication and ending 5 years following article publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Study Data/Documents

  1. Study Protocol
    Information identifier: PMC6792262
    Information comments:

    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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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