Exploration of quality standards for pooled cryoprecipitate coagulation factors
10.13303/j.cjbt.issn.1004-549x.2026.08.019
- VernacularTitle:混合冷沉淀凝血因子质量标准探索
- Author:
Xiaochun LI
1
;
Xingchen. LIU
1
Author Information
1. Chengdu Blood Center, Chengdu 6111020, China
- Publication Type:Journal Article
- Keywords:
pooled cryoprecipitate;
factor Ⅷ;
fibrinogen;
quality standards;
pooled preparation
- From:
Chinese Journal of Blood Transfusion
2026;39(8):1125-1129
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To establish quality standards for pooled cryoprecipitate based on measured data, addressing the issues of wide variability in coagulation factor content attributable to individual donor differences and imprecise clinical dosing with single-bag cryoprecipitate. Methods: A total of 120 bags of fresh frozen plasma of different ABO blood groups were enrolled. Single-bag cryoprecipitate was prepared using either the centrifugation method or the siphonage method. For each blood group and each preparation method, every five single units of the same blood group were pooled into one bag of pooled cryoprecipitate. Factor Ⅷ content, fibrinogen content, and volume were measured in source plasma, single-bag cryoprecipitate, and pooled cryoprecipitate. Recovery rates and coefficients of variation were calculated, and the effect of the pooling process on product homogeneity was analyzed. Results: The factor Ⅷ content, fibrinogen content, and volume of pooled cryoprecipitate were significantly higher than those of single-unit cryoprecipitate and were linearly correlated with the number of units pooled. After pooling, the coefficient of variation for factor Ⅷ content decreased from 34.9%-35.2% (single units) to 18.2%-20.7% (pools), and the coefficient of variation for fibrinogen content decreased from 27.0%-28.6% to 13.1%-13.4%. The pooling procedure had no significant effect on the recovery rates of factor Ⅷ or fibrinogen (P>0.05). Conclusion: For pooled cryoprecipitate prepared by pooling five single units, the proposed quality standards are: factor Ⅷ content≥400 IU/bag, fibrinogen content≥750 mg/bag, volume 200-250 mL/bag, and sterility test negative. These standards can provide a basis for large-scale preparation and clinical application of pooled cryoprecipitate.
