None listed
Conditions
Brief summary
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 10e9/L.
Interventions
Eligible patients will be randomised to receive either prophylactic platelet transfusions if the platelet count is less than 10 x 10e9/L, or no prophylaxis if the platelet count is less than 10e9/L, with therapeutic transfusions given only after documented signs or symptoms of bleeding (World Health Organization [WHO] Grade 2, 3 or 4) or prior to a planned invasive procedure. The duration of the intervention is 30 days from randomisation. Platelet transfusions will be given as a single adult dos
Eligible patients will be randomised to receive either prophylactic platelet transfusions if the platelet count is less than 10 x 10e9/L, or no prophylaxis if the platelet count is less than 10e9/L, with therapeutic transfusions given only after documented signs or symptoms of bleeding (World Health Organization [WHO] Grade 2, 3 or 4) or prior to a planned invasive procedure. The duration of the intervention is 30 days from randomisation. Platelet transfusions will be given as a single adult dose for patients who develop WHO Grade 2 bleeds. For patients who develop WHO Grade 3 or 4 bleeds, the platelet dose will be decided by the attending haematologist.
Sponsors
National Health Service Blood & Transplant
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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 or are going to receive myelosuppressive chemotherapy on this hospital admission with or without haematopoietic stem cell support (this includes patients undergoing haematopoietic stem cell transplantation - autologous or allogeneic) 4. They are thrombocytopenic or expected to become thrombocytopenic with a platelet count of less than 50 x 10e9/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 therapeutic doses of anticoagulants (e.g. heparin), during the whole period of thrombocytopenia 5. They have acute promyelocytic leukaemia and undergoing induction chemotherapy 6. They have known human leukocyte antigen (HLA) antibodies 7. They are pregnant 8. They have previously been randomised in this trial at any stage of their treatment
Outcome results
None listed