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

Conditions

Haematological malignancies Cancer Leukaemia of unspecified cell type

Simon Stanworth, Cara Hudson, Lise J Estcourt, Rachel Johnson, Erica M. Wood et al. (6 authors)

Haematologica2015-03-2075 citations

10.3324/haematol.2014.118075

A no-prophylaxis platelet-transfusion strategy for hematologic cancers.

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, TOPPS Investigators.

2013-05-01315 citations

10.1056/nejmoa1212772

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The percentage of patients who develop a WHO Grade two, three or four bleeding event up to 30 days from randomisation	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

England, United Kingdom

Outcome results

None listed