Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001087246
Ethics application status
Approved
Date submitted
11/12/2009
Date registered
18/12/2009
Date last updated
16/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of prophylactic versus no prophylactic platelet transfusions in patients with haematological malignancies
Scientific title
A randomised controlled trial to compare the incidence of bleeding events following prophylactic versus no prophylactic platelet transfusions in patients with haematological malignancies
Secondary ID [1] 1190 0
International Standard Randomised Controlled Trial Number Register

ISRCTN08758735
Universal Trial Number (UTN)
Trial acronym
Trial Of Prophylactic PlateletS (TOPPS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haematological malignancies 252378 0
Condition category
Condition code
Blood 256557 256557 0 0
Haematological diseases
Cancer 256584 256584 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible patients will be randomised to receive either prophylactic platelet transfusions if the platelet count is less than 10 x 10e9/L, or no prophylaxis if the platelet count is less than 10e9/L, with therapeutic transfusions given only after documented signs or symptoms of bleeding (World Health Organization [WHO] Grade 2, 3 or 4) or prior to a planned invasive procedure. The duration of the intervention is 30 days from randomisation. Platelet transfusions will be given as a single adult dose for patients who develop WHO Grade 2 bleeds. For patients who develop WHO Grade 3 or 4 bleeds, the platelet dose will be decided by the attending haematologist.
Intervention code [1] 255679 0
Treatment: Other
Comparator / control treatment
The comparator treatment is prophylactic platelet transfusions if the platelet count is less than 10 x 10e9/L, following documented signs or symptoms of bleeding (WHO Grade 2, 3 or 4) or prior to planned invasive procedure. A single adult dose will be given on the same day that a platelet count is recorded as less than 10 x 10e9/L and continued daily until the platelet count is greater than 10 x10e9/L. A single adult dose will be given to patients who develop a WHO Grade 2 bleed. For patients who develop WHO Grade 3 0r 4 bleeds, the platelet dose will be decided by the attending haematologist.
The overall duration of the prophylactic treatment is 30 days from randomisation.
Control group
Active

Outcomes
Primary outcome [1] 257446 0
Primary Outcome: The proportion of patients who experience (modified) WHO Grade 2, 3 or 4 bleeding event. The percentage of patients who experience a WHO Grade 2, 3, or 4 bleed by day 30 will be calculated for each arm.
Timepoint [1] 257446 0
30 days after randomisation
Secondary outcome [1] 262586 0
Logistic regression for proportion developing WHO Grade 3 or 4 bleed.
Timepoint [1] 262586 0
30 days after randomisation.
Secondary outcome [2] 262587 0
Cox proportional hazards regression model for time from randomisation to first WHO Grade 2, 3 or 4 bleed.
Timepoint [2] 262587 0
30 days after randomisation
Secondary outcome [3] 262588 0
Rate of bleeding events, as a fraction of the number of days with bleeding events divided by total number of days at risk of bleeding (the period of observation with thrombocytopenia).
Timepoint [3] 262588 0
30 days after randomisation.
Secondary outcome [4] 262589 0
Time from randomisation to second grade two bleed.
Timepoint [4] 262589 0
30 days after randomisation.
Secondary outcome [5] 262590 0
Period in hospital.
Timepoint [5] 262590 0
30 days after randomisation.
Secondary outcome [6] 262591 0
Total number of platelet transfusion episodes.
Timepoint [6] 262591 0
30 days after randomisation.
Secondary outcome [7] 262592 0
Total number of red cell transfusions.
Timepoint [7] 262592 0
30 days after randomisation.

Eligibility
Key inclusion criteria
Patients are eligible for this trial if:
1. They are aged 16 years or over
2. They have a confirmed diagnosis of a haematological malignancy
3. They have received or are going to receive myelosuppressive chemotherapy on this hospital admission with or without haematopoietic stem cell support (this includes patients undergoing haematopoietic stem cell transplantation - autologous or allogeneic)
4. They are thrombocytopenic or expected to become thrombocytopenic with a platelet count of less than 50 x 10e9/L for at least 5 days
5. They are able to comply with treatment and monitoring
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients are not eligible for this trial if:
1. They have had a WHO Grade 3 or 4 bleed during any stage of their treatment to date
2. During the current admission, they have experienced or are currently experiencing a WHO Grade 2 or greater bleed
3. They have any inherited clotting disorder (e.g. haemophilia)
4. They need to remain on regular aspirin (or related drugs), or will require therapeutic doses of anticoagulants (e.g. heparin), during the whole period of thrombocytopenia
5. They have acute promyelocytic leukaemia and undergoing induction chemotherapy
6. They have known human leukocyte antigen (HLA) antibodies
7. They are pregnant
8. They have previously been randomised in this trial at any stage of their treatment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients are identified. If consent is obtained and once the patient’s platelet count falls below 50 x 10e9/L, the patient is randomised to either treatment arm. An independent central on-line 24 hour internet system is used for randomisation at all centres. A unique trial number and treatment policy is assigned and the randomising centre confirms the allocated treatment to the principle investigator (PI) by email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer program at the randomising centre will allocate patients using minimisation with a random element. Minimisation will balance the allocation of treatment policy between centres, patients with different diagnosis, and treatment plan.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2349 0
3002
Recruitment postcode(s) [2] 2350 0
3050
Recruitment postcode(s) [3] 2351 0
5011
Recruitment outside Australia
Country [1] 2359 0
United Kingdom
State/province [1] 2359 0

Funding & Sponsors
Funding source category [1] 256159 0
Government body
Name [1] 256159 0
National Health Service (NHS) Blood & Transplant
Country [1] 256159 0
United Kingdom
Funding source category [2] 256165 0
Charities/Societies/Foundations
Name [2] 256165 0
Australian Red Cross Blood Service
Country [2] 256165 0
Australia
Primary sponsor type
Government body
Name
National Health Service Blood & Transplant
Address
Southmead Road
Bristol
United Kingdom
BS10 5ND
Country
United Kingdom
Secondary sponsor category [1] 251502 0
Charities/Societies/Foundations
Name [1] 251502 0
Australian Red Cross Blood Service
Address [1] 251502 0
Level 6, 646 St Kilda Road
Melbourne
Victoria
3004
Country [1] 251502 0
Australia
Other collaborator category [1] 997 0
Hospital
Name [1] 997 0
Peter MacCallum Cancer Centre
Address [1] 997 0
St Andrew's Place
East Melbourne
Victoria 3002
Country [1] 997 0
Australia
Other collaborator category [2] 998 0
Hospital
Name [2] 998 0
The Royal Melbourne Hospital
Address [2] 998 0
Grattan Street
Parkville
Victoria 3050
Country [2] 998 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258265 0
Australian Red Cross Blood Service Human Research Ethics Committee
Ethics committee address [1] 258265 0
Ethics committee country [1] 258265 0
Australia
Date submitted for ethics approval [1] 258265 0
Approval date [1] 258265 0
29/04/2008
Ethics approval number [1] 258265 0
Application 2008#06
Ethics committee name [2] 258266 0
Peter MacCallum Cancer Centre
Ethics committee address [2] 258266 0
Ethics committee country [2] 258266 0
Australia
Date submitted for ethics approval [2] 258266 0
Approval date [2] 258266 0
23/09/2009
Ethics approval number [2] 258266 0
Project number 09/34
Ethics committee name [3] 258292 0
Central Office of Research Ethics Committees (COREC)
Ethics committee address [3] 258292 0
Ethics committee country [3] 258292 0
United Kingdom
Date submitted for ethics approval [3] 258292 0
Approval date [3] 258292 0
Ethics approval number [3] 258292 0
06/Q1606/8

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

Contacts
Principal investigator
Name 30605 0
Address 30605 0
Country 30605 0
Phone 30605 0
Fax 30605 0
Email 30605 0
Contact person for public queries
Name 13852 0
Dr Erica Wood
Address 13852 0
Australian Red Cross Blood Service
PO Box 354, South Melbourne, VIC, 3205
Country 13852 0
Australia
Phone 13852 0
+61 39 694 0203
Fax 13852 0
+61 39 694 0108
Email 13852 0
[email protected]
Contact person for scientific queries
Name 4780 0
Dr Erica Wood
Address 4780 0
Australian Red Cross Blood Service
PO Box 354, South Melbourne, VIC, 3205
Country 4780 0
Australia
Phone 4780 0
+61 39 694 0203
Fax 4780 0
+61 39 694 0108
Email 4780 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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