Premium
Hemostatic profile and safety of pooled cryoprecipitate up to 120 hours after thawing
Author(s) -
Lokhandwala Parvez M.,
O'Neal Adrian,
Patel Eshan U.,
Brunker Patricia A. R.,
Gehrie Eric A.,
Zheng Gang,
Kickler Thomas S.,
Ness Paul M.,
Tobian Aaron A. R.
Publication year - 2018
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.14550
Subject(s) - cryoprecipitate , fibrinogen , medicine , confidence interval , coagulation , zoology , biology
BACKGROUND AABB standards state that cryoprecipitate should be transfused within 4 to 6 hours after thawing. We evaluated coagulation factor levels and sterility of thawed pooled cryoprecipitate to assess whether shelf life can be safely extended. STUDY DESIGN AND METHODS Donor cryoprecipitate pools (n = 20, 10 group A, 10 group O) were held at ambient temperature and sampled at 0, 4, 8, 24, 48, 72, 96, and 120 hours post‐thawing for fibrinogen, Factor (F)VIII, and von Willebrand factor (vWF) levels. Samples were tested at 0 and 120 hours for sterility (BacT/Alert system). Sixty additional cryoprecipitate pools were evaluated after 72 hours. Longitudinal differences in component levels were determined by linear fixed‐effects regression. RESULTS Group O cryoprecipitate had significantly lower FVIII (p = 0.002) and vWF activity (p = 0.006) compared to group A at 0 hours, but were not statistically different in fibrinogen levels (p = 0.33). Fibrinogen levels were stable over 5 days: 501 ± 81 mg/unit (mean ± standard deviation) at 0 hours to 506 ± 102 mg/unit at 120 hours (p = 0.73). Similarly, there was no decline in vWF activity: 200 ± 53 IU/unit at 0 hours to 209 ± 57 IU/unit at 120 hours (p = 0.084). The FVIII activity significantly declined on average by 9.6 IU (95% confidence interval, 5.5‐13.8) between 0 hours (111 ± 33 IU/unit) and 120 hours post‐thaw (101 ± 33) (p < 0.001). No organisms were detected when cryoprecipitate pools were cultured at 0 hours, but at 120 hours Staphylococcus epidermidis was identified from one pool, potentially a contaminant introduced during repeated sampling. No cultures were positive among the 60 additional cryoprecipitate pools assessed at 72 hours. CONCLUSION Extended cryoprecipitate storage at ambient temperature did not affect fibrinogen levels over 120 hours. Sterility of products held at ambient temperature for an extended period of time could be assessed by secondary culture.