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首页> 外文期刊>Transfusion medicine reviews >Do all patients with hematologic malignancies and severe thrombocytopenia need prophylactic platelet transfusions? Background, rationale, and design of a clinical trial (trial of platelet prophylaxis) to assess the effectiveness of prophylactic platelet transfusions.
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Do all patients with hematologic malignancies and severe thrombocytopenia need prophylactic platelet transfusions? Background, rationale, and design of a clinical trial (trial of platelet prophylaxis) to assess the effectiveness of prophylactic platelet transfusions.

机译：所有血液系统恶性肿瘤和严重血小板减少症的患者都需要预防性血小板输注吗？评估预防性血小板输注有效性的临床试验（血小板预防试验）的背景，原理和设计。

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Although considerable advances have been made in many aspects of platelet transfusion therapy in the last 30 years, some areas continue to provoke debate, including the use of prophylactic platelet transfusions for the prevention of thrombocytopenic bleeding in patients with bone marrow failure. We have designed a randomized controlled trial to compare prophylactic platelet use with a threshold of a platelet count of 10 x 10(9)/L with no prophylaxis in adult thrombocytopenic patients with hematologic malignancies. The trial question is whether a no-prophylactic policy for the use of platelet transfusions in patients with hematologic malignancies is not inferior to a threshold prophylactic policy at 10 x 10(9)/L, for bleeding at World Health Organization (WHO) grade 2, 3, or 4, up to 30 days from randomization. The primary outcome measure is the proportion of patients who have a significant clinical bleed, defined as WHO grade 2 or higher up to 30 days from randomization. Subsidiary clinical outcome measures include time to first bleed and a descriptive analysis of all severe bleeds. A bleeding assessment form is completed daily for all study subjects until day 30 from randomization. Minor modifications were made to the definitions at WHO grades 1 and 2 for petechiae and duration of nose bleeds, after piloting of the bleeding assessment forms. This study has been designed as a 2-stage randomized trial with an interim analysis planned after a minimum of 100 patients had been randomized and had completed their period of observation. Patients have initially been enrolled through 3 United Kingdom hematology centers. The interim analysis has been completed, and the results have confirmed a final sample size of 600 patients. Recruitment is now being extended to other centers in United Kingdom and Australia. Local research nurses are not blinded to treatment allocation, but a number of measures to reduce risk of assessment bias include repeated education around standard operating procedures, common definitions, and duplication of assessments. The expected completion date for the 5-year study is December 2011.
机译：尽管在过去30年中，血小板输注治疗的许多方面都取得了长足的进步，但仍有一些领域引起争议，包括使用预防性血小板输注来预防骨髓衰竭患者的血小板减少性出血。我们设计了一项随机对照试验，以比较预防性血小板使用与血小板计数为10 x 10（9）/ L的阈值，而对于患有血液系统恶性肿瘤的成人血小板减少症患者则没有预防性使用。该试验的问题是，对于血液恶性肿瘤患者使用血小板输注的无预防性政策是否不逊于世界卫生组织（WHO）2级的10 x 10（9）/ L的阈值预防性政策，最多3或4天（从随机分组开始）。主要结局指标是有重大临床出血的患者比例，定义为随机分组后最多30天达到WHO 2级或更高水平。辅助临床结局指标包括首次出血时间和所有严重出血的描述性分析。每天完成所有研究对象的出血评估表，直到随机分组的第30天为止。在尝试使用出血评估表后，对世卫组织1级和2级的瘀点和流鼻血持续时间的定义进行了细微修改。这项研究被设计为一项2期随机试验，并在至少100名患者被随机化并完成了观察期后计划进行中期分析。患者最初已通过3个英国血液学中心入组。中期分析已经完成，结果确认了600名患者的最终样本量。招聘现在正在扩展到英国和澳大利亚的其他中心。本地研究护士对治疗分配并不盲目，但为减少评估偏倚风险的许多措施包括围绕标准操作程序进行反复教育，通用定义以及重复评估。这项为期5年的研究的预计完成日期是2011年12月。

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