Randomisation system
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Overview

A randomised controlled trial comparing prophylactic platelet use with no-prophylaxis in adult thrombocytopenic patients with haematological malignancies.

ISRCTN 08758735

Study design

Two-stage, randomised, non-inferiority study

Inclusion criteria

Patients are eligible for this trial if:

1. They are aged 16 years or over
2. They have a confirmed diagnosis of a haematological malignancy
3. They have received, 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 10⁹/L for at least 5 days
5. They are able to comply with treatment and monitoring

Exclusion criteria

Patients are not eligible for this trial if:

1. They have had a WHO Grade 3 or 4 bleed during any stage of their treatment to date
2. During the current admission, they have experienced or are currently experiencing a WHO Grade 2 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 and undergoing induction chemotherapy
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

Further details

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