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Blood, 12 February 2009, Vol. 113, No. 7, pp. 1564-1573. Prepublished online as a Blood First Edition Paper on December 24, 2008; DOI 10.1182/blood-2008-09-178236. This Article Full Text Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2008-09-178236v1 113/7/1564    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Heddle, N. M. Articles by Lee, K.-A. Search for Related Content PubMed PubMed Citation Articles by Heddle, N. M. Articles by Lee, K.-A. Related Collections Transfusion Medicine Free Research Articles Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  TRANSFUSION MEDICINE A randomized controlled trial comparing standard- and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia Nancy M. Heddle1,2, Richard J. Cook3, Alan Tinmouth2,4, C. Tom Kouroukis1, Tor Hervig5, Ellen Klapper6, Joseph M. Brandwein7, Zbigniew M. Szczepiorkowski8, James P. AuBuchon8, Rebecca L. Barty1, Ker-Ai Lee3, and for the SToP Study investigators of the BEST Collaborative 1 Department of Medicine, McMaster University, Hamilton, ON; 2 Canadian Blood Services, Ottawa, ON; 3 Department of Statistics and Actuarial Science, University of Waterloo, Waterloo, ON; 4 Ottawa Health Research Institute, Ottawa, ON; 5 Haukeland University Hospital, Bergen, Norway; 6 Cedars-Sinai Medical Center, Los Angeles, CA; 7 University Health Network, Toronto, ON; and 8 Dartmouth-Hitchcock Medical Center, Lebanon, NH A noninferiority study was performed comparing low-dose and standard-dose prophylactic platelet transfusions. A double-blind randomized controlled trial (RCT) was performed in 6 sites in 3 countries. Thrombocytopenic adults requiring prophylactic platelet transfusion were randomly allocated to standard-dose (300-600 x 109 platelets/product) or low-dose (150- < 300 x 109 platelets/product) platelets. The primary outcome (World Health Organization [WHO] bleeding grade 2) was assessed daily through clinical examination, patient interview, and chart review. A WHO grade was assigned through adjudication. The Data Safety Monitoring Board stopped the study because the difference in the grade 4 bleeding reached the prespecified threshold of 5%. At this time, 129 patients had been randomized and 119 patients were included in the analysis (58 low dose; 61 standard dose). Three patients in the low-dose arm (5.2%) had grade 4 bleeds compared with none in the standard-dose arm. WHO bleeding grade 2 or higher was 49.2% (30/61) in the standard-dose arm and 51.7% (30/58) in the low-dose group (relative risk [RR], 1.052; 95% confidence interval [CI], 0.737-1.502). A higher rate of grade 4 bleeding in patients receiving low-dose prophylactic platelet transfusions resulted in this RCT being stopped. Whether this finding was due to chance or represents a real difference requires further investigation. These clinical studies are registered on http://www.clinicaltrials.gov as NCT00420914 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

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