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
Protocol serial number	PG04/5
Sponsor	The National Blood Service (UK)
Funder	National Blood Service (UK) - NBS National Research Review Committee approval

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

Primary study design	Interventional
Study design	Randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	The percentage of patients who develop a WHO Grade two, three or four bleeding event up to 30 days from randomisation
Key secondary outcome measure(s)	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.
Completion date	31/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

National Blood Service

Oxford
OX3 9BQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
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.