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A randomised controlled trial of prophylactic versus no-prophylactic platelet transfusions in patients with haematological malignancies
ISRCTN ISRCTN08758735
DOI 10.1186/ISRCTN08758735
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial of prophylactic versus no-prophylactic platelet transfusions in patients with haematological malignancies
Scientific title
Acronym TOPPS
Serial number at source PG04/5
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.
Lay summary http://www.cancerhelp.org.uk/trials/a-trial-looking-at-platelet-transfusions-during-treatment-for-cancer-of-the-blood-or-lymphatic-system
Ethics approval This study was awarded ethics committee approval on 15/03/2006 (REC reference number: 06/Q1606/8).
Study design The study is a randomised controlled study
Countries of recruitment United Kingdom
Disease/condition/study domain Haematological malignancies
Participants - 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
Participants - 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
Anticipated start date 07/07/2006
Anticipated end date 31/07/2011
Status of trial Completed
Patient information material
Target number of participants 600
Interventions 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.
Primary outcome measure(s) 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 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.
Sources of funding National Blood Service (UK) - NBS National Research Review Committee approval.
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23656642
Contact name Dr  Simon  Stanworth
  Address National Blood Service
Oxford Centre, Level 2
John Radcliffe Hospital
  City/town Oxford
  Zip/Postcode OX3 9BQ
  Country United Kingdom
  Tel +44 (0)1865 447917
  Fax +44 (0)1865 447957
  Email simon.stanworth@nbs.nhs.uk
Sponsor The National Blood Service (UK)
  Address Southmead Road
  City/town Bristol
  Zip/Postcode BS10 5ND
  Country United Kingdom
  Tel +44 (0)117 991 2100
  Fax +44 (0)117 959 1660
  Email marion.scott@nbs.nhs.uk
Date applied 31/07/2006
Last edited 13/05/2013
Date ISRCTN assigned 12/09/2006
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