American Red Cross, Holland Lab for the Biomedical Sciences, Rockville, Maryland, USA.
U.S Army Medical Research and Development Command Battlefield Resuscitation for Immediate Stabilization of Combat Casualties Portfolio Combat Casualty Care Research Program Office, USA.
Transfusion. 2022 Feb;62(2):439-447. doi: 10.1111/trf.16785. Epub 2022 Jan 7.
Cold storage reduces posttransfusion survival of platelets; however, it can improve platelet activation, lower risk of bacterial contamination, and extend shelf-life compared to room temperature (RT) storage. To facilitate large-scale availability, manufacturing process optimization is needed, including understanding the impact of variables on platelet potency and safety. Short time requirements from collection to storage is challenging for large blood centers to complete resuspension and qualify platelets for production. This study evaluated the impact of time from platelet component collection to cold storage on in vitro properties and bacterial growth.
Double-apheresis platelet components were collected from healthy donors, suspended in 65% PAS-III/35% plasma, and split into 2 equal units. One unit was placed into cold storage within 2 h and the other unit after 8 h. Eight matched pairs were evaluated for 12 in vitro parameters. Twenty-four matched pairs were evaluated with 8 bacterial strains tested in triplicate. Samples were tested throughout 21 days of storage.
In vitro properties were not different between 2 and 8 h units, and trends throughout storage were similar between arms. Time to cold storage did not significantly impact bacterial growth, with <1 log difference at all timepoints between units.
Our studies showed that extending time to cold storage from 2 to 8 h from collection did not significantly increase the bacterial growth, and the platelet component quality and function is maintained. The ability to extend the time required from collection to storage will improve blood center logistics to feasibly produce CSPs.
冷藏会降低血小板输注后的存活率;然而,与室温(RT)储存相比,它可以改善血小板的激活,降低细菌污染的风险,并延长保存期限。为了便于大规模应用,需要对制造工艺进行优化,包括了解变量对血小板效力和安全性的影响。从采集到储存的时间要求很短,这对大型血库来说是一个挑战,因为他们需要完成重新悬浮并使血小板有资格进行生产。本研究评估了从血小板成分采集到冷藏的时间对体外特性和细菌生长的影响。
从健康供者采集双份单采血小板成分,悬浮于 65% PAS-III/35%血浆中,并分成 2 等份。一份在 2 小时内放入冷藏,另一份在 8 小时后放入冷藏。评估了 8 对 12 项体外参数。评估了 24 对匹配的单位,用 8 种细菌株进行了 3 次重复测试。在 21 天的储存过程中对样本进行了测试。
2 小时和 8 小时单位之间的体外特性没有差异,并且两个臂之间的储存趋势相似。冷藏时间不会显著影响细菌生长,所有时间点的单位之间相差不到 1 个对数。
我们的研究表明,从采集到冷藏的时间从 2 小时延长至 8 小时不会显著增加细菌生长,并且血小板成分的质量和功能得以维持。延长从采集到储存所需时间的能力将改善血库的物流,使其能够更切实地生产 CSPs。