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解冻血浆中凝血因子(F)V、FVII 和 FVIII 长时间储存分析:是否有必要将有效期延长至 5 天以上?

Analysis of prolonged storage on coagulation Factor (F)V, FVII, and FVIII in thawed plasma: is it time to extend the expiration date beyond 5 days?

机构信息

University of Texas Medical School at Houston, Houston, Texas 77030, USA.

出版信息

Transfusion. 2013 Mar;53(3):645-50. doi: 10.1111/j.1537-2995.2012.03786.x. Epub 2012 Jul 15.

DOI:10.1111/j.1537-2995.2012.03786.x
PMID:22803679
Abstract

BACKGROUND

According to AABB standards, fresh-frozen plasma (FFP) should be thawed at 30 to 37°C and expire after 24 hours. An increase in the aggressive management of trauma patients with thawed plasma has heightened the risk of plasma waste. One way to reduce plasma waste is to extend its shelf life, given that the full range of therapeutic efficacy is maintained. We evaluated the effect of prolonged storage at 1 to 6°C on the activity of Factor (F)V, FVII, and FVIII in plasma thawed at 37 or 45°C.

STUDY DESIGN AND METHODS

Group O plasma from healthy donors (n=20) was divided into 10 pairs and frozen and stored at not more than -18°C. One sample from each pair was thawed at 37 or 45°C, and all were stored at 1 to 6°C. Samples were analyzed for FV, FVII, and FVIII activity on Days 0, 5, 10, 15, and 20.

RESULTS

Plasma thawing time was 17% less at 45°C than at 37°C. No differences were observed between thawing groups in coagulation activity of FV, FVII, and FVIII during the 20-day storage period (p>0.12). In both groups, the activity of FV and FVIII decreased over time but remained within a normal range at 10 days.

CONCLUSION

Although levels of plasma clotting factors are reduced in storage, therapeutic levels of FV and FVIII are maintained in thawed plasma stored for up to 10 days at 1 to 6°C. Thawing of FFP at 45°C decreases thawing time but does not affect the activity of FV, FVII, and FVIII.

摘要

背景

根据 AABB 标准,新鲜冷冻血浆(FFP)应在 30 至 37°C 下解冻,并在 24 小时后失效。由于解冻血浆的创伤患者积极管理的增加,增加了血浆浪费的风险。减少血浆浪费的一种方法是延长其保质期,因为保持了其全部治疗功效。我们评估了在 1 至 6°C 下长时间储存对在 37 或 45°C 解冻的血浆中 F 因子(FV)、FVII 和 FVIII 活性的影响。

研究设计和方法

从健康供体(n=20)采集 O 型血浆并将其分为 10 对,冷冻并储存在不超过-18°C 以下。每对的一个样本在 37 或 45°C 下解冻,并在 1 至 6°C 下储存。在第 0、5、10、15 和 20 天分析所有样本的 FV、FVII 和 FVIII 活性。

结果

在 45°C 下解冻时间比在 37°C 下缩短了 17%。在 20 天的储存期间,在解冻组之间未观察到 FV、FVII 和 FVIII 凝血活性的差异(p>0.12)。在两组中,FV 和 FVIII 的活性随时间推移而降低,但在 10 天内仍保持在正常范围内。

结论

尽管在储存过程中血浆凝血因子水平降低,但在 1 至 6°C 下储存 10 天内解冻的血浆中,FV 和 FVIII 的治疗水平仍保持在正常范围内。在 45°C 下解冻 FFP 可缩短解冻时间,但不影响 FV、FVII 和 FVIII 的活性。

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