Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Dr Simon Stanworth


Contact details

National Blood Service
Oxford Centre
Level 2
John Radcliffe Hospital
United Kingdom
+44 (0)1865 447917

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Haematological malignancies


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



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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

National Blood Service
United Kingdom

Sponsor information


The National Blood Service (UK)

Sponsor details

Southmead Road
BS10 5ND
United Kingdom
+44 (0)117 991 2100

Sponsor type

Research organisation



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


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:
2014 cost analysis results in:
2014 subgroup analysis results in:

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes