Retention of hemostatic and immunological properties of frozen plasma and COVID ‐19 convalescent apheresis fresh‐frozen plasma produced and freeze‐dried in Canada Academic Article uri icon

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abstract

  • Background

    Randomized clinical trial data show that early plasma transfusion may save lives among trauma patients. Supplying plasma in remote environments is logistically challenging. Freeze-dried plasma (FDP) offers a possible solution.

    Study design and methods

    A Terumo BCT plasma freeze-drying system was evaluated. We compared pooled frozen plasma (FP) units with derived Terumo BCT FDP (TFDP) units and pooled COVID-19 convalescent apheresis fresh-frozen plasma (CC-AFFP) with derived CC-TFDP units. Parameters measured were: coagulation factors (F) II; V; VII; VIII; IX; XI; XIII; fibrinogen; Proteins C (PC) and S (PS); antithrombin (AT); α2 -antiplasmin (α2 AP); ADAMTS13; von Willebrand Factor (vWF); thrombin-antithrombin (TAT); D-dimer; activated complement factors 3 (C3a) and 5 (C5a); pH; osmolality; prothrombin time (PT); and activated partial thromboplastin time (aPTT). Antibodies to SARS-CoV-2 in CC-AFFP and CC-TFDP units were compared by plaque reduction assays and viral protein immunoassays.

    Results

    Most parameters were unchanged in TFDP versus FP or differed ≤15%. Mean aPTT, PT, C3a, and pH were elevated 5.9%, 6.9%, 64%, and 0.28 units, respectively, versus FP. CC-TFDP showed no loss of SARS-CoV-2 neutralization titer versus CC-AFFP and no mean signal loss in most pools by viral protein immunoassays.

    Conclusion

    Changes in protein activities or clotting times arising from freeze-drying were <15%. Although C3a levels in TFDP were elevated, they were less than literature values for transfusable plasma. SARS-CoV-2-neutralizing antibody titers and viral protein binding levels were largely unaffected by freeze-drying. In vitro characteristics of TFDP or CC-TFDP were comparable to their originating plasma, making future clinical studies appropriate.

authors

  • Sheffield, William
  • Bhakta, Varsha
  • Howell, Anita
  • Jenkins, Craig
  • Serrano, Katherine
  • Johnson, Nathaniel
  • Lin, Yi‐Chan J
  • Colwill, Karen
  • Rathod, Bhavisha
  • Greenberg, Brianna
  • Gingras, Anne‐Claude
  • Evans, David H
  • Flaumenhaft, Elissa
  • Beckett, Andrew
  • Drews, Steven J
  • Devine, Dana V

publication date

  • February 2022