ISRCTN08758735
Completed
Phase 3
A randomised controlled trial of prophylactic versus no-prophylactic platelet transfusions in patients with haematological malignancies
The National Blood Service (UK)0 sites600 target enrollmentSeptember 12, 2006
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The National Blood Service (UK)
- Enrollment
- 600
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23656642 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24826894 cost analysis results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24724863 subgroup analysis results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25795717 results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34263930/ (added 10/11/2021)
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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