A randomised controlled trial of prophylactic versus no-prophylactic platelet transfusions in patients with haematological malignancies
ISRCTN | ISRCTN08758735 |
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DOI | https://doi.org/10.1186/ISRCTN08758735 |
Secondary identifying numbers | PG04/5 |
- Submission date
- 31/07/2006
- Registration date
- 12/09/2006
- Last edited
- 24/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Simon Stanworth
Scientific
Scientific
National Blood Service
Oxford Centre, Level 2
John Radcliffe Hospital
Oxford
OX3 9BQ
United Kingdom
Phone | +44 (0)1865 447917 |
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simon.stanworth@nbs.nhs.uk |
Study information
Study design | Randomised controlled study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | A randomised controlled trial of prophylactic versus no-prophylactic platelet transfusions in patients with haematological malignancies |
Study acronym | TOPPS |
Study objectives | The trial hypothesis is that a policy of no prophylactic platelet transfusion is as safe as (or non-inferior to) a policy of prophylactic transfusion, based on a threshold peripheral blood platelet count of less than 10 x 10^9/L. |
Ethics approval(s) | This study was awarded ethics committee approval on 15/03/2006, REC ref: 06/Q1606/8 |
Health condition(s) or problem(s) studied | Haematological malignancies |
Intervention | Eligible patients will be randomised to receive either prophylactic platelet transfusions if the platelet count is less than 10x10^9/L, or no prophylaxis with therapeutic transfusions given only after documented signs or symptoms of bleeding. |
Intervention type | Other |
Primary outcome measure | The percentage of patients who develop a WHO Grade two, three or four bleeding event up to 30 days from randomisation |
Secondary outcome measures | These will follow the same strategy as for the primary outcome using regression modelling techniques to adjust for the three stratifying factors. In particular: 1. Logistic regression for proportion developing grade 3 or 4 bleed - subsidiary outcome measure: 1.1. Cox proportional hazards regression model for time to first WHO grade two, three, or four bleed 1.2. Time from randomisation to second grade two bleed 1.3. Period in hospital 1.4. Poisson regression for the rate of bleeding events Descriptive analyses will be presented for other outcomes. |
Overall study start date | 07/07/2006 |
Completion date | 31/07/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 600 |
Key inclusion criteria | 1. They are aged 16 years or over 2. They have a confirmed diagnosis of a haematological malignancy 3. They are receiving or are going to receive myelosuppressive chemotherapy on this hospital admission with or without haematopoietic stem cell support (this includes patients undergoing haemopoietic stem cell transplantation - autograft or allograft) 4. They are thrombocytopenic or expected to become thrombocytopenic with a platelet count of less than 50 x 10^9/L for at least five days 5. They are able to comply with treatment and monitoring |
Key exclusion criteria | 1. They have had a World Health Organization (WHO) Grade three or four bleed (refer to Modified WHO Bleeding Criteria) during any stage of their treatment to date 2. During the current admission, they have experienced or are currently experiencing a WHO Grade two 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 regular therapeutic doses of anticoagulants (heparin), during the whole period of thrombocytopenia 5. They have acute promyelocytic leukaemia 6. They have known HLA antibodies 7. They are pregnant 8. They have previously been randomised in this trial at any stage of their treatment |
Date of first enrolment | 07/07/2006 |
Date of final enrolment | 31/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
National Blood Service
Oxford
OX3 9BQ
United Kingdom
OX3 9BQ
United Kingdom
Sponsor information
The National Blood Service (UK)
Research organisation
Research organisation
Southmead Road
Bristol
BS10 5ND
United Kingdom
Phone | +44 (0)117 991 2100 |
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marion.scott@nbs.nhs.uk | |
https://ror.org/0227qpa16 |
Funders
Funder type
Research organisation
National Blood Service (UK) - NBS National Research Review Committee approval
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan | Not provided at time of registration |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 09/05/2013 | Yes | No | |
Results article | cost analysis results | 01/10/2014 | Yes | No | |
Results article | subgroup analysis results | 01/10/2014 | Yes | No | |
Results article | results | 01/06/2015 | Yes | No | |
Results article | 01/09/2021 | 10/11/2021 | Yes | No | |
Plain English results | 24/01/2022 | No | Yes |
Editorial Notes
24/01/2022: A link to plain English results was added.
10/11/2021: Publication reference added.
15/02/2016: Publication reference added.
On 22/02/2011 the overall trial end date was changed from 07/07/2008 to 31/07/2011.