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解冻血浆的五天稳定性:溶剂/去污剂处理的血浆与新鲜冷冻血浆以及24小时内冷冻的血浆相当。

Five-day stability of thawed plasma: solvent/detergent-treated plasma comparable with fresh-frozen plasma and plasma frozen within 24 hours.

作者信息

Neisser-Svae Andrea, Trawnicek Laurenz, Heger Andrea, Mehta Trupti, Triulzi Darrell

机构信息

Scientific & Medical Affairs, Octapharma, Hoboken, New Jersey.

Clinical Research Biometrics, Octapharma, Vienna, Austria.

出版信息

Transfusion. 2016 Feb;56(2):404-9. doi: 10.1111/trf.13356. Epub 2015 Sep 29.

Abstract

BACKGROUND

Plasma stored refrigerated for up to 5 days after thawing is common practice in many US hospitals. Therefore, clotting factor activities in fresh-frozen plasma (FFP), plasma frozen within 24 hours (PF24), and solvent/detergent-treated plasma (SDP), thawed and stored at 1 to 6°C for up to 5 days, were investigated.

STUDY DESIGN AND METHODS

Five A, B, O, and AB units of FFP, PF24, and SDP were thawed and maintained for 5 days at 1 to 6°C. The activity of factor (F)V, FVII, FVIII, protein S (PS), and ADAMTS13 was determined in each unit at baseline and every 24 hours thereafter for 5 days.

RESULTS

After thaw, mean values of the variables tested were within the normal range in all three plasma products although, in SDP, FVIII activity was significantly lower (p = 0.0039). After 5 days of storage all factors significantly declined except for ADAMTS13 activity, which was stable. Mean FVIII and ADAMTS13 activity was comparable in all three plasma products and within the normal range, mean FV activity was significantly lower in FFP and PF24 (p<0.0001) compared to SDP, and mean FVII activity was significantly lower in PF24 (p<0.03) than in FFP or SDP. Mean PS activity was below the normal range in all three plasma products with the lowest values in SDP (p = 0.0001).

CONCLUSION

Over 5 days of refrigerated storage the changes in the measured coagulation factors in FFP, PF24, and SDP are comparable. Clinical follow-up is needed to assess whether slightly lower PS levels in SDP are clinically important.

摘要

背景

在美国许多医院,解冻后的血浆冷藏保存长达5天是常见做法。因此,对新鲜冰冻血浆(FFP)、24小时内冰冻的血浆(PF24)和溶剂/去污剂处理的血浆(SDP)在1至6°C解冻并保存长达5天的凝血因子活性进行了研究。

研究设计与方法

将5个A、B、O和AB型单位的FFP、PF24和SDP解冻,并在1至6°C下保存5天。在基线时以及此后每24小时对每个单位的因子(F)V、FVII、FVIII、蛋白S(PS)和ADAMTS13活性进行测定,持续5天。

结果

解冻后,尽管SDP中的FVIII活性显著较低(p = 0.0039),但所有三种血浆制品中所测变量的平均值均在正常范围内。储存5天后,除ADAMTS13活性稳定外,所有因子均显著下降。所有三种血浆制品中FVIII和ADAMTS13的平均活性相当且在正常范围内,与SDP相比,FFP和PF24中的平均FV活性显著较低(p<0.0001),PF24中的平均FVII活性显著低于FFP或SDP(p<0.03)。所有三种血浆制品中PS的平均活性均低于正常范围,SDP中的值最低(p = 0.0001)。

结论

在冷藏保存5天期间,FFP、PF24和SDP中所测凝血因子的变化相当。需要进行临床随访以评估SDP中略低的PS水平在临床上是否重要。

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