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Trial record 25 of 420 for:    TRANEXAMIC ACID

TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia (TREATT)

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ClinicalTrials.gov Identifier: NCT03136445
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : December 14, 2018
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Monash University
Information provided by (Responsible Party):
NHS Blood and Transplant

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.

Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Hemorrhage Hematopoietic Stem Cell Transplantation Drug: Tranexamic acid (TXA). Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 616 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Study Start Date : June 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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:
  • Cyklokapron®
  • trans-4-(aminomethyl)cyclohexanecarboxylic acid
  • Lysteda

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 Name: Placebo for tranexamic acid




Primary Outcome Measures :
  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. [ 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.



Secondary Outcome Measures :
  1. Proportion of days with bleeding (WHO grade 2 or above) up to Study Day 30. [ 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Number of thrombotic events from first administration of trial treatment up to and including 120 days after the first dose of trial treatment is administered, per day at risk. [ Time Frame: Up to and including 120 days from the first administration of investigational medicinal product (IMP). ]
    Measured by calculating number of clinically diagnosed thrombotic events from Treatment Day 1 i.e the first day that the investigational medicinal product (IMP) is administered, up to and including the next 120 days.

  9. 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.

  10. All-cause mortality during the first 30 days and 120 days after the first dose of trial treatment is administered. 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.

  11. 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.

  12. 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

  13. 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.


Other Outcome Measures:
  1. 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.

  2. Reasons for platelet and red cell transfusions. [ Time Frame: Measured during first 30 days from first dose of IMP. ]
    Reasons for platelet and red cell transfusions as documented by clinician.

  3. Proportion of days with fever [ Time Frame: Measured during first 30 days from first dose of IMP. ]
    Highest daily temperature ≥ 38.1°C



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136445


Contacts
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Contact: Gillian Powter, RGN BA gillian.powter@nhsbt.nhs.uk

Locations
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Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia
Royal Brisbane Recruiting
Brisbane, Australia
Canberra Hospital Recruiting
Canberra, Australia
Andrew Love Cancer Centre Recruiting
Geelong, Australia
Alfred Hospital Recruiting
Melbourne, Australia
St Vincent's Hospital Recruiting
Melbourne, Australia
Victorian Comprehensive Cancer Centre Recruiting
Melbourne, Australia
Royal North Shore Hospital Recruiting
St Leonards, Australia
St Vincent's Hospital Recruiting
Sydney, Australia
Westmead Hospital Recruiting
Westmead, Australia
United Kingdom
Royal United Hospital Active, not recruiting
Bath, United Kingdom
Belfast City Hospital Recruiting
Belfast, United Kingdom
Heartlands Hospital Recruiting
Birmingham, United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom
Bristol Haematology and Oncology Centre Recruiting
Bristol, United Kingdom
University Hospital Coventry Recruiting
Coventry, United Kingdom
Royal Devon and Exeter Hospital Recruiting
Exeter, United Kingdom
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom
St James's Hospital Recruiting
Leeds, United Kingdom
Lincoln County Hospital Recruiting
Lincoln, United Kingdom
King's College Hospital Recruiting
London, United Kingdom
University College London Hospitals Recruiting
London, United Kingdom
Freeman Hospital Recruiting
Newcastle, United Kingdom
Churchill Hospital Recruiting
Oxford, United Kingdom
Derriford Hospital Recruiting
Plymouth, United Kingdom
Salisbury District Hospital Recruiting
Salisbury, United Kingdom
Royal Hallamshire Hospital Not yet recruiting
Sheffield, United Kingdom
Sponsors and Collaborators
NHS Blood and Transplant
National Health and Medical Research Council, Australia
Monash University
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NHS Blood and Transplant
ClinicalTrials.gov Identifier: NCT03136445     History of Changes
Other Study ID Numbers: 12-01-CSU
2014-001513-35 ( EudraCT Number )
ISRCTN73545489 ( Registry Identifier: ISRCTN Registry )
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by NHS Blood and Transplant:
Tranexamic acid
Platelet transfusion
Additional relevant MeSH terms:
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Tranexamic Acid
Hematologic Neoplasms
Thrombocytopenia
Hemorrhage
Pathologic Processes
Blood Platelet Disorders
Hematologic Diseases
Neoplasms by Site
Neoplasms
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants