Challenging the 30‐min rule for thawed plasma

Abstract

Background and Objectives Frozen plasma (FP) is thawed prior to transfusion and stored for ≤5 days at 1–6°C. The effect of temperature excursions on the quality and safety of thawed plasma during 5‐day storage was determined. Materials and Methods Four plasma units were pooled, split and stored at ≤−18°C for ≤90 days. Test units T30 and T60 were exposed to 20–24°C (room temperature [RT]) for 30 or 60 min, respectively, on days 0 and 2 of storage. Negative and positive control units remained refrigerated or at RT for 5 days, respectively. On Day 5, test units were exposed once to RT for 5 h. Quality assays included stability of coagulation factors FV, FVII, FVIII, fibrinogen and prothrombin time. Bacterial growth was performed in units inoculated with ~1 CFU/ml or ~100 CFU/ml of Serratia liquefaciens, Pseudomonas putida, Pseudomonas aeruginosa or Staphylococcus epidermidis on Day 0. Results Testing results of all quality parameters were comparable between T30 and T60 units (p < 0.05). Serratia liquefaciens proliferated in cold‐stored plasma, while P. putida showed variable viability. Serratia epidermidis and P. aeruginosa survived but did not grow in cold‐stored plasma. Positive and negative controls showed expected results. Overall, no statistical differences in bacterial concentration between T30 and T60 units were observed (p < 0.05). Conclusion Multiple RT exposures for 30 or 60 min do not affect the stability of coagulation factors or promote bacterial growth in thawed plasma stored for 5 days. It is therefore safe to expose thawed plasma to uncontrolled temperatures for limited periods of 60 min.

Evaluation of bacterial growth, effects on albumin, and coagulation factors in canine fresh frozen plasma administered as continuous rate infusion exposed to room temperature for 12 hours

“…Similar to the results of the current study, significant microbial growth does not occur in liquid human platelets held at room temperature for less than 24 hours 15 . In another study in people, multiple room temperature exposures for 60 minutes in thawed plasma stored for 5 days did not affect the stability of coagulation factors or promote bacterial growth 16 . While the risk of bacterial contamination in canine FFP kept at room temperature has not been previously evaluated in dogs, in other previous studies, bacterial growth did not occur in never‐frozen refrigerated or thawed refrigerated canine plasma despite storage for up to 42 days 17,18 .…”

“…Therefore, the number of units studied in the current study could be insufficient to detect bacterial contamination in FFP units exposed at room temperature for 12 hours. On the other hand, the risk of bacterial contamination in blood products could be related to the length of exposure time at room temperature 14–16 . In the current study, keeping the units for 12 hours at room temperature might not provide enough time to allow bacterial growth.…”

“…15 In another study in people, multiple room temperature exposures for 60 minutes in thawed plasma stored for 5 days did not affect the stability of coagulation factors or promote bacterial growth. 16 While the risk of bacterial contamination in canine FFP kept at room temperature has not been previously evaluated in dogs, in other previous studies, bacterial growth did not occur in never-frozen refrigerated or thawed refrigerated canine plasma despite storage for up to 42 days. 17,18 Another study revealed that canine-specific albumin, when refrigerated at 4 • C, can be stored for up to 24 hours after reconstitution without evidence of bacterial growth.…”

“…On the other hand, the risk of bacterial contamination in blood products could be related to the length of exposure time at room temperature. [14][15][16] In the current study, keeping the units for 12 hours at room temperature might not provide enough time to allow bacterial growth. Similar to the results of the current study, significant microbial growth does not occur in liquid human platelets held at room temperature for less than 24 hours.…”

Experiences in the use of multiple doses of convalescent plasma in critically ill patients with COVID‐19: An early phase 1 descriptive study

“…In our study, the research team concluded that the adverse events observed were unlikely to be associated with CCP transfusion owing to the following reasons: (i) the timing of each adverse event exceeded the window period for plasma transfusion-related adverse events; and (ii) all CCP units were processed and stored at −70°C to prevent bacterial proliferation, suggesting that even if patients experienced bacteremia, bacterial contamination from the administered plasma could be ruled out. 27 Moreover, the standard practice of our blood bank involves weekly quality control checks to monitor bacterial growth in every blood product. All the CCP units used for this study were thawed following the same sterile procedure and transfused within 60 min, a practice demonstrated to be safe for preserving sterility.…”