Canadian Blood Services, Ottawa, Ontario, Canada.
Transfusion. 2012 Dec;52(12):2683-91. doi: 10.1111/j.1537-2995.2012.03752.x. Epub 2012 Jun 28.
A semiautomated method of component production from whole blood was implemented at Canadian Blood Services. To assess safety of the new components, the frequency of adverse transfusion events (ATEs) to platelet components (PCs) and red blood cell (RBCs) produced before and after implementation of the new method was surveyed and compared.
This retrospective, observational, noninferiority study was conducted in 12 sentinel hospitals across Canada. The control group received RBCs in additive solution-3 (AS-3) and platelet-rich plasma (PRP)-produced platelets (PLTs) for 3 to 11 months before implementation of semiautomated production, and the study group received RBCs in saline-adenine-glucose-mannitol (SAGM) and buffy coat (BC)-produced PLTs for 3 to 11 months after implementation. ATE definitions at each hospital and standard practice for reporting did not change between control and study periods. Data for analysis were obtained from databases and original report forms.
The pooled risk ratio of a reaction to SAGM versus AS-3 RBCs was 0.77 (95% confidence interval [CI], 0.66-0.90), suggesting that SAGM products had significantly lower reaction rates than AS-3 products (p < 0.01). Reported allergic reactions to RBCs decreased from 0.07% (AS-3) to 0.04% (SAGM). For PLTs, the difference in reaction rates between BC and PRP was not significant (p = 0.37), and the pooled risk ratio of BC versus PRP was 1.14 (95% CI, 0.86-1.50).
The change in manufacturing method was associated with lower reaction rates to SAGM RBCs than to AS-3 RBCs. Pooled BC PLTs were noninferior to random-donor PRP PLTs with respect to ATEs.
加拿大血液服务中心实施了一种从全血中半自动生产成分的方法。为了评估新成分的安全性，调查并比较了实施新方法前后血小板成分（PCs）和红细胞（RBCs）不良输血事件（ATEs）的频率。
这是一项在加拿大 12 家监测医院进行的回顾性、观察性、非劣效性研究。对照组在半自动生产实施前的 3 至 11 个月内接受添加溶液-3（AS-3）和富含血小板血浆（PRP）制备的血小板（PLTs）的 RBCs，研究组在半自动生产实施后的 3 至 11 个月内接受生理盐水-腺嘌呤-葡萄糖-甘露醇（SAGM）和浓缩白细胞（BC）制备的 PLTs 的 RBCs。每个医院的 ATE 定义和报告标准实践在对照和研究期间没有改变。分析数据来自数据库和原始报告表。
SAGM 与 AS-3 RBCs 反应的风险比为 0.77（95%置信区间[CI]，0.66-0.90），表明 SAGM 产品的反应率明显低于 AS-3 产品（p<0.01）。报告的 RBCs 过敏反应从 0.07%（AS-3）降至 0.04%（SAGM）。对于 PLTs，BC 与 PRP 之间的反应率差异无统计学意义（p=0.37），BC 与 PRP 的风险比为 1.14（95%CI，0.86-1.50）。
制造方法的改变与 SAGM RBCs 的反应率低于 AS-3 RBCs 相关。BC 血小板的汇总结果与随机供体 PRP 血小板在 ATE 方面没有差异。
