Background, rationale, and design of a clinical trial to assess the effects of platelet dose on bleeding risk in thrombocytopenic patients

Journal of Clinical Apheresis
S J Slichter

Abstract

Outlined is the background and rationale for the initiation of a randomized prospective platelet transfusion trial to evaluate the effects of platelet dose on hemostasis and platelet utilization rates. This clinical trial is being performed by the newly established Transfusion Medicine/Hemostasis Clinical Trial Network supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. The trial will randomize 1,350 patients into three platelet transfusion arms based on body surface area (BSA). The lower dose will be 1.1 x 10(11) platelets/m(2), the medium dose will be 2.2 x 10(11) platelets/m(2), and the higher dose will be 4.4 x 10(11) platelets/m(2). The primary outcome measure will be the incidence of Grade 2 bleeding; i.e., gross hemorrhage without the need for red cell transfusion. Major secondary outcome measures will be the total number of platelets transfused, the total number of platelet transfusion events, the highest grade of bleeding, and bleeding severity. It is expected that this clinical trial will change platelet transfusion practice by identifying whether low-dose platelet transfusion therapy provides adequate hemostasis and what is the most cost-effective strategy for providing pl...Continue Reading

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Citations

Feb 19, 2010·The New England Journal of Medicine·Sherrill J SlichterSuzanne Granger
Nov 21, 2007·Hematology·Sherrill J Slichter
Dec 17, 2008·Hematology·Morris A BlajchmanMichael F Murphy
May 27, 2010·F1000 Medicine Reports·Neil BlumbergGordon L Phillips
Nov 1, 2011·Transfusion clinique et biologique : journal de la Société française de transfusion sanguine·O Erhabor, T C Adias
Nov 26, 2009·Transfusion and Apheresis Science : Official Journal of the World Apheresis Association : Official Journal of the European Society for Haemapheresis·Pieter F van der MeerAnneke Brand
Apr 18, 2008·Transfusion clinique et biologique : journal de la Société française de transfusion sanguine·M Lozano, J Cid
Aug 2, 2007·Hematology/oncology Clinics of North America·Sherrill J Slichter
Feb 6, 2007·Transfusion and Apheresis Science : Official Journal of the World Apheresis Association : Official Journal of the European Society for Haemapheresis·Araba Afenyi-AnnanNicholas Bandarenko
Oct 14, 2009·Journal of Veterinary Emergency and Critical Care·Mary Beth CallanBruce S Sachais
Jan 15, 2009·Transfusion·Richard M Kaufman
Nov 13, 2008·Transfusion·Richard J Cook, Nancy M Heddle
Sep 29, 2012·Journal of Veterinary Emergency and Critical Care·Bryan D Hux, Linda G Martin
May 28, 2011·British Journal of Haematology·Lise J EstcourtM F Murphy
Mar 24, 2016·Cytotechnology·Retno Wahyu NurhayatiMasahito Taya
Jul 5, 2016·Journal of Veterinary Emergency and Critical Care·Zenithson Y NgJoe W Bartges
Mar 17, 2010·Journal of Infusion Nursing : the Official Publication of the Infusion Nurses Society·Seth Eisenberg
Nov 19, 2010·Expert Review of Hematology·Joan Cid, Miguel Lozano

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