Condition category
Cancer
Date applied
31/07/2006
Date assigned
12/09/2006
Last edited
13/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

The study is a 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

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23656642

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.

Additional files

Editorial Notes