Hemostatic profile and safety of pooled cryoprecipitate up to 120 hours after thawing

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Abstract

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.

Original languageEnglish (US)
JournalTransfusion
DOIs
StateAccepted/In press - Jan 1 2018

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Hemostatics
Fibrinogen
Infertility
Safety
von Willebrand Factor
Temperature
Blood Coagulation Factors
Staphylococcus epidermidis
Confidence Intervals

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Hematology

Cite this

@article{8cd0375d052a4f92a4d6a25ebe337cdd,
title = "Hemostatic profile and safety of pooled cryoprecipitate up to 120 hours after thawing",
abstract = "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.",
author = "Parvez Lokhandwala and Adrian O'Neal and Patel, {Eshan U.} and Brunker, {Patricia Ann Ramaley} and Eric Gehrie and Gang Zheng and Kickler, {Thomas Stephen} and Ness, {Paul Michael} and Tobian, {Aaron A}",
year = "2018",
month = "1",
day = "1",
doi = "10.1111/trf.14550",
language = "English (US)",
journal = "Transfusion",
issn = "0041-1132",
publisher = "Wiley-Blackwell",

}

TY - JOUR

T1 - Hemostatic profile and safety of pooled cryoprecipitate up to 120 hours after thawing

AU - Lokhandwala, Parvez

AU - O'Neal, Adrian

AU - Patel, Eshan U.

AU - Brunker, Patricia Ann Ramaley

AU - Gehrie, Eric

AU - Zheng, Gang

AU - Kickler, Thomas Stephen

AU - Ness, Paul Michael

AU - Tobian, Aaron A

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

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U2 - 10.1111/trf.14550

DO - 10.1111/trf.14550

M3 - Article

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JF - Transfusion

SN - 0041-1132

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