Background, rationale, and design of a clinical trial to assess the effects of platelet dose on bleeding risk in thrombocytopenic patients.
Background, rationale, and design of a clinical trial to assess the effects of platelet dose on bleeding risk in thrombocytopenic patients.
复制标题
评估血小板剂量对血小板减少症患者出血风险影响的临床试验的背景、基本原理和设计。
DOI：
10.1002/jca.20090
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发表时间：
2006
期刊：
影响因子：
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通讯作者：
Slichter,SherrillJ
中科院分区：
文献类型：
--
作者：
Slichter,SherrillJ
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 × 1011platelets/m2, the medium dose will be 2.2 × 1011platelets/m2, and the higher dose will be 4.4 × 1011platelets/m2. 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 platelet transfusions. J. Clin. Apheresis 21: 78–84, 2006. © 2006 Wiley‐Liss, Inc.
