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在体外对使用 Trima Accel 系统采集的血小板进行的一项试点研究,并在冷藏温度(1-6°C)下储存在 T-PAS+溶液中。

An in vitro pilot study of apheresis platelets collected on Trima Accel system and stored in T-PAS+ solution at refrigeration temperature (1-6°C).

机构信息

Coagulation and Blood Research Program, U.S. Army Institute of Surgical Research, Fort Sam Houston, Texas.

Texas A&M Health Science Center, Bryan, Texas.

出版信息

Transfusion. 2019 May;59(5):1789-1798. doi: 10.1111/trf.15150. Epub 2019 Feb 6.

Abstract

BACKGROUND

Using platelet additive solution (PAS) to dilute fibrinogen during long-term cold storage of platelets (PLTs) decreases PLT activation and increases functional PLT shelf life. We performed a randomized, paired study to assess the in vitro quality of PLTs stored in the cold in T-PAS+ for up to 18 days evaluated against PLTs stored under currently allowable conditions (5-day room temperature-stored PLTs [RTP] and 3-day cold-stored PLTs [CSP]).

STUDY DESIGN AND METHODS

PLTs were collected from healthy volunteers (n = 10) and diluted to 65% T-PAS+/35% plasma before cold storage. Double-dose apheresis PLTs (in 100% plasma) were collected from the same donors and split into two bags (one bag RTP, one bag CSP). All bags were sampled on the day of collection (Day 0). CSP and RTP bags were sampled on Days 3 and 5, respectively. T-PAS+ samples were assessed on Days 3, 5, 14, 16, and 18 of storage for metabolism, hemostatic function, and activation.

RESULTS

After 18 days of storage in T-PAS+, pH was 6.71 ± 0.04, PLT count was comparable to Day 3 CSP, PLT function (aggregation and clot strength) was comparable to Day 5 RTP, and PLT activation was significantly increased.

CONCLUSION

Refrigerated PLTs stored in T-PAS+ for 18 days met FDA pH standards. Functional metrics suggest activity of T-PAS+-stored PLTs and the potential to contribute to hemostasis throughout 18 days of storage. Extending the shelf life of PLTs would increase access to hemostatic resuscitation for bleeding patients in military and civilian settings.

摘要

背景

在血小板(PLT)的长期冷藏中使用血小板添加剂溶液(PAS)稀释纤维蛋白原可降低 PLT 的激活程度并延长功能性 PLT 的保存期限。我们进行了一项随机配对研究,以评估在 T-PAS+中冷藏保存长达 18 天的 PLT 的体外质量,与目前允许的条件下(5 天室温保存的 PLT [RTP]和 3 天冷藏保存的 PLT [CSP])相比。

研究设计和方法

从健康志愿者(n=10)中采集 PLT,并在冷藏前稀释至 65% T-PAS+/35%血浆。从同一供体采集双剂量单采 PLT(100%血浆),并将其分为两个袋子(一个 RTP 袋,一个 CSP 袋)。所有袋子均在采集当天(第 0 天)取样。CSP 和 RTP 袋分别在第 3 天和第 5 天取样。T-PAS+样本在冷藏的第 3、5、14、16 和 18 天评估代谢、止血功能和激活情况。

结果

在 T-PAS+中储存 18 天后,pH 值为 6.71±0.04,PLT 计数与第 3 天的 CSP 相当,PLT 功能(聚集和凝块强度)与第 5 天的 RTP 相当,而 PLT 激活明显增加。

结论

在 T-PAS+中冷藏保存 18 天的 PLT 符合 FDA pH 标准。功能指标表明 T-PAS+-储存的 PLT 的活性以及在 18 天的储存过程中有助于止血的潜力。延长 PLT 的保质期将增加军事和平民环境中出血患者止血复苏的机会。

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