冷沉淀凝血因子制备质量的影响因素分析

Analysis of factors influencing the quality of cryoprecipitate coagulation factors

目的研究采血时间、制备时间、制备方法、速冻方法对冷沉淀凝血因子质量的影响。方法随机选取2017年10月~2018年3月采集的200ml全血,分别在6、8、13、18h这四个时间段内制备成新鲜冰冻血浆,每段为25份新鲜冰冻血浆,相应做好标识,之后加工成冷沉淀凝血因子,对其中的Ⅷ因子含量、纤维蛋白原含量进行检测。结果各个时间段下由新鲜冰冻血浆制备而成的冷沉淀凝血因子中的Ⅷ因子含量活性随着制备时间的延长明显下降(P<0.05),而各时间段的纤维蛋白原含量比较,差异无统计学意义(P>0.05)。与18h的质量合格率比较,采血后6、8、13h的质量合格率均显著增高,差异有统计学意义(P<0.05)。6、8、13h这三个时间段的质量合格率比较,差异无统计学意义(P>0.05)。结论为保证冷沉淀凝血因子制备质量,应对全血采集时间进行控制,200ml要求在7min以内采完,400ml要求在13min内采完,并在6~8h内、最长不要超过13h分离新鲜冰冻血浆作为原料浆,同时建议使用平板速冻机的制备方法,以满足临床输注应用的有效性和安全性。

Objective To study the influence of blood collecting time,preparation time,preparation method and quick freezing method on the quality of cryoprecipitated coagulation factor.Methods A total of 200 ml whole blood collected from October 2017 to March 2018 was randomly selected to prepare fresh frozen plasma within 6,8,13 and 18 hours,each of which contained 25 fresh frozen plasma samples,which were marked accordingly,and then processed into cryoprecipitated coagulation factors.The content of factor Ⅷ and fibrinogen were detected.Results The activity content of factor Ⅷ in cryoprecipitated coagulation factor prepared from fresh frozen plasma decreased significantly with the prolongation of preparation time (P<0.05).There was no significant difference in fibrinogen content among different time periods (P>0.05).Compared with the qualified rate of 18 hours,the qualified rate of 6,8 and 13 hours after blood collection was significantly higher,and the difference was statistically significant (P<0.05).There was no significant difference in the quality qualification rate among the three periods of 6,8 and 13 hours (P>0.05).Conclusion In order to ensure the preparation quality of the cryoprecipitated coagulation factor,the collection time of whole blood should be controlled,of which 200 ml whole blood should be collected within 7 minutes,400 ml within 13 minutes,and fresh frozen plasma should be separated into material plasma within 6-8 hours,no longer than 13 hours after blood collection.At the same time,it is also suggested to use the preparation method of plate freezer so as to satisfy the validity and safety of clinical transfusion and application.