Non-inferiority of a new advanced dry plasma thawing system compared to leading standard method: Preservation of coagulation and anticoagulation proteins necessary for use in the clinic.

Abstract

e14675 Background: Cancer can affect the bone marrow, cause anemia and internal or excess bleeding, requiring blood or plasma transfusion. Fresh frozen plasma (FFP) should be thawed before transfusing to patients but it must be monitored closely to avoid contamination, uncontrolled or prolonged thawing which may subsequently lead to plasma protein denaturation. In this study, we compared and evaluated the effect of two different thawing methods on clotting factor activities as well as factors such as throughput and turnaround time. Methods: Over a period of approximately one month, November 6 to December 3, 2018, our testing laboratory at the UCSD School of Medicine received three sets of samples for a total of 197 freshly collected (pre-freeze) or freshly thawed plasma samples (standard commercial thawing device and the new dry ZipThaw device) that had been collected and processed in accordance with a San Diego Blood Bank protocol described elsewhere. The Lab conducted over 1,782 tests on these plasma for the following factors: Prothrombin time (PT), International Normalized Ratios (INR), Activated Partial Thromboplastin time (aPTT) Factor VIII activity, Factor V activity, Protein C activity, Protein S antigen, Von Willebrand activity and Thrombin Antithrombin Complex (TAT) concentration. The assays were carried out on an ACL TOP 700 Hemostasis Analyzer (Instrumentation Laboratory, Bedford, MA, USA) using manufacturer’s reagents and automated protocols. The ACL TOP 700 has validated precision CV of 5- 10%. All assays were completed within 4 hours of collection or, if frozen, within 4 hours of thawing. The statistical analysis method employed is two-tailed, student t-test. Results: We observed 100% concordance with no statistically significant differences between the pre-freeze group and the two different post thaw groups, except for a slight increase in the mean TAT complex concentration. Overall, the means of all three groups were well within the normal range defined by the assay kits (1-10 ng/ml). Further, the increased mean TAT is more notable with standard method (33%, p = 0.004) than with the ZipThaw (18%, p = 0.054). Conclusions: We report for the first time non-inferiority between the new ZipThaw device and the leading commercial predicate in plasma thawing while preserving coagulation and anticoagulation proteins and minimizing activation of clotting cascade. The results provide support for the use of ZipThaw device in clinical settings.