Research and Development, CaridianBCT, Inc, Lakewood, CO, USA.
Vox Sang. 2010 Jul 1;99(1):34-43. doi: 10.1111/j.1423-0410.2010.01313.x. Epub 2010 Feb 23.
The haemolysis level at the end of storage is a performance parameter for RBC preparations. In the evaluation of new devices or new processes for processing blood, it is relevant to evaluate whether the haemolysis is linked to (1) specific characteristics of the blood donor, or (2) the nature of the blood-processing methodologies.
As part of the validation of a new automated whole blood processing system compared to the current manual methods, randomized, paired crossover studies were conducted evaluating measures of blood component quality, including RBC haemolysis over 42 days of storage.
The association between haemolysis and the individual subject was evaluated by modelling haemolysis with independent predictors of treatment (control and test processing) and leucocyte reduction as fixed factors with donor and laboratory as random effects in a mixed-effects ANOVA model. It was found that the day 42 haemolysis values were strongly dependent on the donor subject, with an intraclass correlation coefficient of 0.81.
The data reported in this study suggest a link between the specific whole blood donor and the haemolysis levels observed in red-blood-cell units stored refrigerated for 42 days. Additional research to identify possible donor characteristics associated with haemolysis during storage is warranted.
储存期末的溶血水平是红细胞制剂的一个性能参数。在评估新设备或血液处理新工艺时，有必要评估溶血是否与（1）献血者的特定特征有关，或（2）血液处理方法的性质有关。
作为与当前手动方法相比对新的自动化全血处理系统进行验证的一部分，进行了随机、配对交叉研究，评估了血液成分质量的测量指标，包括储存 42 天期间的 RBC 溶血。
通过将溶血与独立的处理预测因子（对照和测试处理）以及白细胞减少建模，将溶血与个体受试者相关联，将供体和实验室作为随机效应固定在混合效应 ANOVA 模型中。发现第 42 天的溶血值与供体受试者密切相关，组内相关系数为 0.81。
本研究报告的数据表明，冷藏储存 42 天的红细胞单位中观察到的溶血水平与特定的全血供体之间存在联系。需要进一步研究以确定与储存期间溶血相关的可能供体特征。
