Hematologic NeoplasmsPhase 3TREATTNCT03136445
TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia
A Phase 3 study testing Tranexamic acid (TXA). in people with Hematologic Neoplasms and Hemorrhage, run by NHS Blood and Transplant at 27 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms, Hemorrhage, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Tranexamic acid (TXA).
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 616 participants
- Where
- 27 sitesin 2 countries
- Study dates
- Jun 2015to 18 Jun 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
- Patients receiving anticoagulant therapy or anti-platelet therapy
- Patients with visible haematuria at time of randomisation
- Patients with anuria (defined as urine output < 10 mls/hr over 24 hours).
- Patients with severe renal impairment (eGFR ≤30 ml/min/1.73m²)
- Patients with a previous history of epilepsy, convulsions, fits or seizures
- Patients who are pregnant or breast-feeding
- Allergic to tranexamic acid.
- Patients enrolled in other trials involving platelet transfusions, anti-fibrinolytics, platelet growth factors or other pro-coagulant agents.
- Patients previously randomised into this trial at any stage of their treatment.
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United Kingdom16 sites
Royal United Hospital
Bath
Belfast City Hospital
Belfast
Heartlands Hospital
Birmingham
Queen Elizabeth Hospital
Birmingham
Bristol Haematology and Oncology Centre
Bristol
University Hospital Coventry
Coventry
Royal Devon and Exeter Hospital
Exeter
Beatson West of Scotland Cancer Centre
Glasgow
St James's Hospital
Leeds
Lincoln County Hospital
Lincoln
King's College Hospital
London
University College London Hospitals
London
Freeman Hospital
Newcastle
Churchill Hospital
Oxford
Derriford Hospital
Plymouth
Salisbury District Hospital
Salisbury
Australia11 sites
Royal Adelaide Hospital
Adelaide
Royal Brisbane
Brisbane
Canberra Hospital
Canberra
Andrew Love Cancer Centre
Geelong
Alfred Hospital
Melbourne
Monash Health
Melbourne
St Vincent's Hospital
Melbourne
Victorian Comprehensive Cancer Centre
Melbourne
Royal North Shore Hospital
St Leonards
St Vincent's Hospital
Sydney
Westmead Hospital
Westmead
About this study
Official title: 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.
Read the 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.
- Being tested
- Tranexamic acid (TXA)., Placebo
- Keywords
- Tranexamic acid, Platelet transfusion
- Medical subject headings
- Hematologic Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid (TXA).Drug
Also called Cyklokapron®, trans-4-(aminomethyl)cyclohexanecarboxylic acid, Lysteda
IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.
PlaceboDrug
Also called Placebo for tranexamic acid
IV (saline) or oral placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. Receives: Drug: Tranexamic acid (TXA). |
| Control Arm | Placebo comparator | Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Number of days where WHO grade 2 or above bleeding has been recorded bleeding using WHO bleeding criteria.
Measured: 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.
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.
Measured: The first 30 days from first dose of trial treatment.
Highest Grade of Bleeding a Patient Experiences up to Study Day 30.
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
Measured: The first 30 days from first dose of trial treatment.
Number of Platelet Transfusions Per Patient up to Study Day 30.
Measured by number of recorded platelet transfusions per patient.
Measured: The first 30 days from first dose of trial treatment.
Number of Red Cell Transfusions Per Patient up to Study Day 30.
Measured by number of recorded red cell transfusions per patient.
Measured: The first 30 days from first dose of trial treatment.
Proportion of Patients Surviving at Least 30 Days Without a Platelet Transfusion.
Measured by calculating number of patients surviving at least 30 days without a platelet transfusion.
Measured: The first 30 days from first dose of trial treatment.
Proportion of Patients Surviving at Least 30 Days Without a Red Cell Transfusion.
Measured by calculating the number of patients surviving at least 30 days without a red cell transfusion.
Measured: 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)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Measured by calculating number of deaths due to bleeding during the first 30 days
Measured: 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.
Measured by calculating the total number of SAE's reported from first administration of IMP.
Measured: Up to and including 60 days from the first administration of IMP.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study startJun 2015
- Primary completion18 Feb 2022
- Study completion18 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 616 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Blood and Transplant
- Sponsor type
- Other government
- Collaborators
- National Health and Medical Research Council, Australia, Monash University
- Responsible party
- Sponsor
- Investigators
- Lise J Estcourt, MBBChir MSc DPhil MRCP FRCPath, Principal investigator, NHS Blood and TransplantZoe K McQuilten, MBBS PhD, Principal investigator, Monash UniversitySimon J Stanworth, DPhil FRCP FRCPath, Principal investigator, NHS Blood and TransplantErica M Wood, MB BS, FRACP, FRCPA, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136445
- Sponsor's protocol ID
- 12-01-CSU
- Other IDs
- 2014-001513-35, ISRCTN73545489, 2014
- Acronym
- TREATT
- Status last verified
- Sep 2025
- First submitted
- 21 Feb 2017
- Last updated
- 28 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39642900Estcourt 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.
PubMed 31615553
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised Controlled Trial Evaluating the Safety and Efficacy of Antifibrinolytics (Tranexamic Acid) in Patients With Haematological Malignancies With Severe Thrombocytopenia
- ClinicalTrials.gov ID
- NCT03136445
- Acronym / sponsor ID
- TREATT / 12-01-CSU
- Keywords
- Tranexamic acid, Platelet transfusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 616 participants (actual)
- Lead sponsor
- NHS Blood and TransplantOther government
- Collaborators
- National Health and Medical Research Council, Australia, Monash University
- Study start
- Jun 2015 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Jun 2022 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Posted 28 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: Tranexamic acid (TXA).Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO. |
| Control Arm | Placebo comparator | Drug: PlaceboPlacebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid (TXA).Also: Cyklokapron®, trans-4-(aminomethyl)cyclohexanecarboxylic acid, LystedaIV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid. | Drug | Intervention Arm |
| PlaceboAlso: Placebo for tranexamic acidIV (saline) or oral placebo tablets | Drug | Control Arm |
Primary outcome
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.
13 secondary outcomes
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 .
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.
Highest Grade of Bleeding a Patient Experiences up to Study Day 30.
Time frame: 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.
Number of Red Cell Transfusions Per Patient up to Study Day 30.
Time frame: 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.
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.
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).
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39642900TREATT 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.
- Derived from this study: PubMed 31615553Estcourt 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.
- 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 trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise J Estcourt, MBBChir MSc DPhil MRCP FRCPath principal investigator
NHS Blood and Transplant
Zoe K McQuilten, MBBS PhD principal investigator
Monash University
Simon J Stanworth, DPhil FRCP FRCPath principal investigator
NHS Blood and Transplant
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic acid (TXA). in people with Hematologic Neoplasms and Hemorrhage, run by NHS Blood and Transplant at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03136445, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2025; AzTrials last refreshed its copy on 26 Oct 2026.