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2012 - 2018年生物制品有效性和安全性倡议电子健康记录网络中评估的血小板使用模式。

Patterns of platelet use evaluated in EHR networks of the Biologics Effectiveness and Safety Initiative, 2012-2018.

作者信息

Villa Carlos H, Biondich Paul, Draper Nicole L, Dores Graça M, Storch Emily, Chada Kinnera, Wong Hui-Lee, Whitaker Barbee, Obidi Joyce, Vossoughi Sarah, Soares Andrey, Schilling Lisa M, Natarajan Karthik, Goodman Michael, Purkayastha Saptarshi, Zucker Rachel, Falconer Thomas, Williams Nerissa, Reich Christian, Anderson Steven, Shoaibi Azadeh

机构信息

Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Regenstrief Institute, Indianapolis, Indiana, USA.

出版信息

Transfusion. 2025 Feb;65(2):267-276. doi: 10.1111/trf.18114. Epub 2024 Dec 22.

Abstract

BACKGROUND

U.S. FDA's Center for Biologics Evaluation and Research (CBER) Biologics Effectiveness and Safety (BEST) Initiative leverages large electronic health records and administrative claims data to conduct active surveillance for CBER-regulated products. Improved hemovigilance of platelet transfusions provides exposure data for future outcome studies and can identify opportunities to improve management of the limited platelet supply.

METHODS

Platelet utilization in three hospital networks (2012-2018) is summarized from data obtained using Information Standard for Blood and Transplant (ISBT) 128 platelet codes. Transfusion episodes, the number of units transfused, and component characteristics are described.

RESULTS

Most platelet-transfused patients (range 59.6%-62.2% across study years for all sites) received platelets once per year and used a small proportion of the total platelets transfused per year (range 18.4%-22.5%). In contrast, a minority of patients were transfused 12 or more times in a given study year (range 4.4%-6.3%) and used a plurality of transfused platelets (range 32.2%-44.4%) per year. The overall ratio of platelets transfused to the number of patients receiving any platelet transfusion was stable over the study period (range 3.9-4.5 platelets/patient) and similar among participating data sources. For all data sources, most transfusion episodes (78%) involved one component per transfusion episode.

CONCLUSION

ISBT 128 coding in the BEST Initiative was used to capture platelet transfusion events, component modifications, and characterize aspects of platelet use patterns. These data can be leveraged to identify opportunities for improved management of the platelet supply and provide granular exposure information for future studies of transfusion-related adverse events.

摘要

背景

美国食品药品监督管理局(FDA)生物制品评估和研究中心(CBER)的生物制品有效性和安全性(BEST)计划利用大型电子健康记录和行政索赔数据,对CBER监管的产品进行主动监测。加强血小板输注的血液警戒可为未来的结局研究提供暴露数据,并可发现改善有限血小板供应管理的机会。

方法

从使用血液和移植信息标准(ISBT)128血小板编码获得的数据中总结了三个医院网络(2012 - 2018年)的血小板使用情况。描述了输血事件、输注的单位数量和成分特征。

结果

大多数接受血小板输注的患者(所有研究年份所有站点的范围为59.6% - 62.2%)每年接受一次血小板输注,且使用的血小板占每年输注血小板总数的比例较小(范围为18.4% - 22.5%)。相比之下,少数患者在给定的研究年份接受了12次或更多次输血(范围为4.4% - 6.3%),且每年使用的输注血小板数量较多(范围为32.2% - 44.4%)。在研究期间,输注的血小板与接受任何血小板输注的患者数量的总体比例保持稳定(范围为3.9 - 4.5个血小板/患者),且在参与的数据源中相似。对于所有数据源,大多数输血事件(78%)每次输血事件涉及一种成分。

结论

BEST计划中的ISBT 128编码用于记录血小板输血事件、成分改变,并描述血小板使用模式的各个方面。这些数据可用于确定改善血小板供应管理的机会,并为未来输血相关不良事件的研究提供详细的暴露信息。

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