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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03136445




Registration number
NCT03136445
Ethics application status
Date submitted
21/02/2017
Date registered
2/05/2017

Titles & IDs
Public title
TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia
Scientific title
A Double-blind, Randomised Controlled Trial Evaluating the Safety and Efficacy of Antifibrinolytics (Tranexamic Acid) in Patients With Haematological Malignancies With Severe Thrombocytopenia
Secondary ID [1] 0 0
2014-001513-35
Secondary ID [2] 0 0
12-01-CSU
Universal Trial Number (UTN)
Trial acronym
TREATT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hematologic Neoplasms 0 0
Hemorrhage 0 0
Hematopoietic Stem Cell Transplantation 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tranexamic acid (TXA).
Treatment: Drugs - Placebo

Experimental: Intervention Arm - Tranexamic acid (TXA). Dose schedule TXA 1g every eight hours IV or 1.5g every eight hours PO.

Placebo comparator: Control Arm - Placebo (saline) if administration is IV. Placebo tablet matched for appearance to TXA if oral.


Treatment: Drugs: Tranexamic acid (TXA).
IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.

Treatment: Drugs: Placebo
IV (saline) or oral placebo tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
The first 30 days from first dose of trial treatment
Secondary outcome [1] 0 0
Proportion of days with bleeding (WHO grade 2 or above) up to Study Day 30.
Timepoint [1] 0 0
The first 30 days from first dose of trial treatment .
Secondary outcome [2] 0 0
Time to first episode of bleeding of WHO grade 2 or greater up to study day 30.
Timepoint [2] 0 0
The first 30 days from first dose of trial treatment.
Secondary outcome [3] 0 0
Highest grade of bleeding a patient experiences up to study day 30.
Timepoint [3] 0 0
The first 30 days from first dose of trial treatment.
Secondary outcome [4] 0 0
Number of platelet transfusions per patient up to study day 30.
Timepoint [4] 0 0
The first 30 days from first dose of trial treatment.
Secondary outcome [5] 0 0
Number of red cell transfusions per patient up to study day 30.
Timepoint [5] 0 0
The first 30 days from first dose of trial treatment.
Secondary outcome [6] 0 0
Proportion of patients surviving at least 30 days without a platelet transfusion.
Timepoint [6] 0 0
The first 30 days from first dose of trial treatment.
Secondary outcome [7] 0 0
Proportion of patients surviving at least 30 days without a red cell transfusion.
Timepoint [7] 0 0
The first 30 days from first dose of trial treatment.
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Up to and including 120 days from the first administration of investigational medicinal product (IMP).
Secondary outcome [9] 0 0
Number of patients developing Veno-occlusive Disease (VOD; Sinusoidal obstructive syndrome, SOS) within 60 days of first administration of trial treatment.
Timepoint [9] 0 0
Up to and including 60 days from the first administration of IMP.
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Up to and including 120 days from the first administration of IMP.
Secondary outcome [11] 0 0
Death due to thrombosis during the first 120 days after the first dose of trial treatment is administered.
Timepoint [11] 0 0
Up to and including 120 days from the first administration of IMP.
Secondary outcome [12] 0 0
Death due to bleeding during the first 30 days after the first dose of trial treatment is administered.
Timepoint [12] 0 0
Up to and including 30 days from the first administration of IMP.
Secondary outcome [13] 0 0
Number of serious adverse events (SAE) from first administration of trial treatment until 60 days after the first dose of trial treatment is administered.
Timepoint [13] 0 0
Up to and including 60 days from the first administration of IMP.

Eligibility
Key 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 =10x10?/L for = 5 days
5. Able to comply with treatment and monitoring
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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/?L 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 design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/06/2022
Sample size
Target
Accrual to date
Final
616
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Brisbane - Brisbane
Recruitment hospital [3] 0 0
Canberra Hospital - Canberra
Recruitment hospital [4] 0 0
Andrew Love Cancer Centre - Geelong
Recruitment hospital [5] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Monash Health - Melbourne
Recruitment hospital [7] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [8] 0 0
Victorian Comprehensive Cancer Centre - Melbourne
Recruitment hospital [9] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [10] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [11] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Canberra
Recruitment postcode(s) [4] 0 0
- Geelong
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- St Leonards
Recruitment postcode(s) [7] 0 0
- Sydney
Recruitment postcode(s) [8] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Bath
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Belfast
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Birmingham
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Bristol
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Coventry
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Exeter
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Glasgow
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Leeds
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Lincoln
Country [10] 0 0
United Kingdom
State/province [10] 0 0
London
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Newcastle
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Oxford
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Plymouth
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Salisbury

Funding & Sponsors
Primary sponsor type
Government body
Name
NHS Blood and Transplant
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lise J Estcourt, MBBChir MSc DPhil MRCP FRCPath
Address 0 0
NHS Blood and Transplant
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
9 months after publication and ending 5 years following article publication.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03136445