Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Simon Stanworth
ORCID ID
Contact details
National Blood Service
Oxford Centre
Level 2
John Radcliffe Hospital
Oxford
OX3 9BQ
United Kingdom
+44 (0)1865 447917
simon.stanworth@nbs.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PG04/5
Study information
Scientific title
A randomised controlled trial of prophylactic versus no-prophylactic platelet transfusions in patients with haematological malignancies
Acronym
TOPPS
Study hypothesis
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.
As of 22/02/2011 the anticipated end date for this trial has been updated from 07/07/2008 to 31/07/2011.
Ethics approval
This study was awarded ethics committee approval on 15/03/2006 (REC reference number: 06/Q1606/8).
Study design
Randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase III
Drug names
Primary outcome measures
The primary outcome measure is the percentage of patients who develop a WHO Grade two, three or four bleeding event up to 30 days from randomisation. The percentage of patients a WHO Grade two, three or four bleed by day 30 will be calculated for each arm.
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 trial start date
07/07/2006
Overall trial end date
31/07/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant 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
Recruitment start date
07/07/2006
Recruitment end date
31/07/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
National Blood Service
Oxford
OX3 9BQ
United Kingdom
Sponsor information
Organisation
The National Blood Service (UK)
Sponsor details
Southmead Road
Bristol
BS10 5ND
United Kingdom
+44 (0)117 991 2100
marion.scott@nbs.nhs.uk
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
National Blood Service (UK) - NBS National Research Review Committee approval.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23656642
2014 cost analysis results in: http://www.ncbi.nlm.nih.gov/pubmed/24826894
2014 subgroup analysis results in: http://www.ncbi.nlm.nih.gov/pubmed/24724863
Publication citations
-
Results
Stanworth SJ, Estcourt LJ, Powter G, Kahan BC, Dyer C, Choo L, Bakrania L, Llewelyn C, Littlewood T, Soutar R, Norfolk D, Copplestone A, Smith N, Kerr P, Jones G, Raj K, Westerman DA, Szer J, Jackson N, Bardy PG, Plews D, Lyons S, Bielby L, Wood EM, Murphy MF, , A no-prophylaxis platelet-transfusion strategy for hematologic cancers., N. Engl. J. Med., 2013, 368, 19, 1771-1780, doi: 10.1056/NEJMoa1212772.
-
Results
Campbell HE, Estcourt LJ, Stokes EA, Llewelyn CA, Murphy MF, Wood EM, Stanworth SJ; TOPPS Study Investigators, Prophylactic platelet transfusions in patients with blood malignancies: cost analysis of a randomized trial, Transfusion, 2014 , 54, 10, 2394-2403, doi: 10.1111/trf.12697.
-
Results
Stanworth SJ, Estcourt LJ, Llewelyn CA, Murphy MF, Wood EM; TOPPS Study Investigators, Impact of prophylactic platelet transfusions on bleeding events in patients with hematologic malignancies: a subgroup analysis of a randomized trial, Transfusion, 2014, 54, 10, 2385-2393, doi: 10.1111/trf.12646.