Erickson Anna, Waldhaus Katie, David Tovo, Huang Norman, Rico Salvador, Corash Laurence, Mufti Nina, Benjamin Richard J
Cerus Corporation, Concord, California.
Transfusion. 2017 Apr;57(4):997-1006. doi: 10.1111/trf.13973. Epub 2017 Feb 1.
Plasma thawed and stored at 1 to 6 C for up to 5 days (thawed plasma [TP]) provides rapid availability in emergencies and reduces plasma waste, but it carries risks of coagulation factor loss or activation, bacterial outgrowth, and viral contamination. We characterized changes in amotosalen/ultraviolet A (UVA) light pathogen-reduced, fresh-frozen plasma (FFP) and plasma frozen within 24 hours (PF24) with post-thaw storage.
Amotosalen/UVA light-treated FFP and PF24 were thawed after approximately 3 to more than 12 months of frozen storage and held at 1 to 6 C for 5 days. Global assessments of coagulation and hemostatic, antithrombotic, and activation markers indicative of function were assessed.
Day 5, thawed amotosalen/UVA light-treated FFP and PF24 contained levels of Factors II, V, VIII, IX, X, von Willebrand factor ristocetin cofactor (vWF:RCo), fibrinogen, antithrombin III (ATIII), protein C, and protein S similar to the levels measured in Day 5 TP, as described in the Circular of Information. Thrombin generation was robust on Day 5 (amotosalen/UVA: FFP = 1866 ± 402 nM/minute; PF24 = 1800 ± 277 nM/minute). Most factor activities on Day 5, including von Willebrand factor-cleaving protease (ADAMTS-13), were more than 90% of Day 0 values, except for known labile Factors V and VIII and protein S. All units contained greater than 0.4 IU/mL protein S and α2 plasmin inhibitor on Day 5. Global functional indices, including thrombin-antithrombin complexes, nonactivated thromboplastin time, and thrombin-generation peak height, did not indicate activation of the coagulation cascade, although isolated units showed raised levels of Factor VIIa and Complement 3a.
Amotosalen/UVA light-treated FFP and PF24 demonstrated retention of procoagulant and antithrombotic activity after 5 days post-thaw storage at 1 to 6 C.
血浆解冻后在1至6摄氏度下储存长达5天(解冻血浆[TP])可在紧急情况下快速取用并减少血浆浪费,但存在凝血因子丢失或激活、细菌滋生和病毒污染的风险。我们对经氨甲环酸/紫外线A(UVA)光处理降低病原体的新鲜冰冻血浆(FFP)和24小时内冰冻的血浆(PF24)解冻后储存期间的变化进行了特征描述。
经氨甲环酸/UVA光处理的FFP和PF24在冷冻储存约3至12个月以上后解冻,并在1至6摄氏度下保存5天。对凝血和止血、抗血栓形成以及指示功能的激活标志物进行了全面评估。
第5天,经氨甲环酸/UVA光处理的解冻FFP和PF24中,因子II、V、VIII、IX、X、血管性血友病因子瑞斯托霉素辅因子(vWF:RCo)、纤维蛋白原、抗凝血酶III(ATIII)、蛋白C和蛋白S的水平与《信息通报》中描述的第5天TP中测得的水平相似。第5天凝血酶生成活跃(氨甲环酸/UVA:FFP = 1866 ± 402 nM/分钟;PF24 = 1800 ± 277 nM/分钟)。第5天大多数因子活性,包括血管性血友病因子裂解蛋白酶(ADAMTS - 13),超过第0天值的90%,已知不稳定的因子V、VIII和蛋白S除外。第5天所有单位的蛋白S和α2纤溶酶抑制剂含量均大于0.4 IU/mL。尽管个别单位显示因子VIIa和补体3a水平升高,但包括凝血酶 - 抗凝血酶复合物、未激活的凝血活酶时间和凝血酶生成峰值高度在内的整体功能指标并未表明凝血级联反应被激活。
经氨甲环酸/UVA光处理的FFP和PF24在1至6摄氏度解冻后储存5天后,显示出促凝血和抗血栓形成活性的保留。