A randomised controlled trial of prophylactic versus no-prophylactic platelet transfusions in patients with haematological malignancies

ISRCTN ISRCTN08758735
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

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-platelet-transfusions-during-treatment-for-cancer-of-the-blood-or-lymphatic-system

Contact information

Dr Simon Stanworth
Scientific

National Blood Service
Oxford Centre, Level 2
John Radcliffe Hospital
Oxford
OX3 9BQ
United Kingdom

Phone +44 (0)1865 447917
Email simon.stanworth@nbs.nhs.uk

Study information

Study designRandomised controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised controlled trial of prophylactic versus no-prophylactic platelet transfusions in patients with haematological malignancies
Study acronymTOPPS
Study objectivesThe 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) studiedHaematological malignancies
InterventionEligible 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 typeOther
Primary outcome measureThe percentage of patients who develop a WHO Grade two, three or four bleeding event up to 30 days from randomisation
Secondary outcome measuresThese 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 date07/07/2006
Completion date31/07/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants600
Key inclusion criteria1. 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 criteria1. 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 enrolment07/07/2006
Date of final enrolment31/07/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

National Blood Service
Oxford
OX3 9BQ
United Kingdom

Sponsor information

The National Blood Service (UK)
Research organisation

Southmead Road
Bristol
BS10 5ND
United Kingdom

Phone +44 (0)117 991 2100
Email marion.scott@nbs.nhs.uk
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.