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Clinical Trials/ISRCTN08758735
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)

Registry
who.int
Start Date
September 12, 2006
End Date
July 31, 2011
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
The National Blood Service (UK)

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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