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

Phase 3

Completed

• Conditions: Haematological malignancies; Cancer; Leukaemia of unspecified cell type

• Registration Number: ISRCTN08758735
• Lead Sponsor: The National Blood Service (UK)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-12
• Study Completion: 2011-07-31
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified