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解冻后冷藏长达 5 天内凝血因子活性和邻苯二甲酸二(2-乙基己基)酯含量在冷冻血浆单位中的变化。

Changes in coagulation factor activity and content of di(2-ethylhexyl)phthalate in frozen plasma units during refrigerated storage for up to five days after thawing.

机构信息

Research and Development and Product and Hospital Services, Canadian Blood Services, Hamilton, Ontario, Canada.

出版信息

Transfusion. 2012 Mar;52(3):493-502. doi: 10.1111/j.1537-2995.2011.03300.x. Epub 2011 Aug 24.

DOI:10.1111/j.1537-2995.2011.03300.x
PMID:21883262
Abstract

BACKGROUND

Thawed plasma is typically transfused to supply coagulation factors but factor activity declines during refrigerated storage. Refrigerating thawed plasma for longer than 24 hours could reduce plasma wastage and make plasma more readily available for emergency transfusions. We measured coagulation factor activity and di(2-ethylhexyl)phthalate (DEHP) concentration in frozen plasma (FP) thawed and stored at 1 to 6°C for up to 5 days.

STUDY DESIGN AND METHODS

FP units prepared using "top-and-bottom" collection sets were thawed, refrigerated, and sampled aseptically at 0, 24, 72, and 120 hours after thawing (n = 54). Clotting factor activities and prothrombin times (PTs) were measured using an automated coagulation factor analyzer. DEHP was measured by high-performance liquid chromatography after hexane extraction (n = 11). Unit sterility was confirmed using an automated microbial detection system.

RESULTS

Factor (F)V and FVIII, but not FVII, declined significantly within 24 hours. By Day 5, mean losses were 20, 14, and 41%, in FV, FVII, and FVIII, respectively; fibrinogen activity did not change. PT values were prolonged by 9% on Day 5. Mean DEHP levels increased from 22 ppm at thaw to 66 ppm on Day 5.

CONCLUSIONS

The bulk of coagulation factor activity losses during storage occurred in the first 24 hours. Coagulation factor activities remaining in FP after 5 days did not differ from those previously reported in similar products frozen within 24 hours of phlebotomy. While DEHP levels in 5-day-thawed FP are not of concern for adult patients, for infants, DEHP levels can be minimized by using FP refrigerated for no more than 24 hours.

摘要

背景

解冻后的血浆通常用于补充凝血因子,但在冷藏储存过程中,因子活性会下降。将解冻后的血浆冷藏储存超过 24 小时,可以减少血浆浪费,并使血浆更易于紧急输血使用。我们测量了冷冻血浆(FP)解冻后在 1 至 6°C 下冷藏储存长达 5 天的凝血因子活性和邻苯二甲酸二(2-乙基己基)酯(DEHP)浓度。

研究设计和方法

使用“顶-底”采集套件制备的 FP 单位在解冻后 0、24、72 和 120 小时无菌取样(n = 54),进行冷藏,并在自动凝血因子分析仪上测量凝血因子活性和凝血酶原时间(PT)。使用高效液相色谱法(HPLC)在正己烷提取后测量 DEHP(n = 11)。使用自动微生物检测系统确认单位无菌。

结果

FV 和 FVIII 因子(但不是 FVII 因子)在 24 小时内显著下降。到第 5 天,FV、FVII 和 FVIII 的平均损失分别为 20%、14%和 41%;纤维蛋白原活性没有变化。第 5 天 PT 值延长 9%。DEHP 水平从解冻时的 22ppm 增加到第 5 天的 66ppm。

结论

在储存过程中,大量凝血因子活性损失发生在最初的 24 小时内。在 5 天后 FP 中剩余的凝血因子活性与先前在采血后 24 小时内冷冻的类似产品中报道的活性没有差异。虽然 5 天解冻后的 FP 中的 DEHP 水平对成年患者没有影响,但对于婴儿,通过将 FP 冷藏不超过 24 小时,可以将 DEHP 水平降到最低。

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