Challenging the 30-min rule for thawed plasma.

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.

Thawing times and hemostatic assessment of fresh frozen plasma thawed at 37°C and 45°C using water-bath methods.

BACKGROUND: The Barkey Plasmatherm (BP; Barkey GmbH & Co. KG) can thaw plasma at 37°C and 45°C. No studies have assessed thawing times or hemostatic qualities of plasma thawed at 45°C with BP. This study assessed fresh frozen plasma (FFP) thawing times with use of BP at 37°C and 45°C and Thermogenesis ThermoLine (TT; Helmer Scientific) at 37°C and compared the hemostatic quality of LG-Octaplas (Octapharma) with use of BP at 37°C and 45°C with TT at 37°C. STUDY DESIGN AND METHODS: The thawing time of FFP (pairs or fours) was assessed using BP at 37°C and 45°C (not prewarmed and prewarmed) and TT at 37°C. Hemostasis was assessed in LG-Octaplas at 5 minutes, 24 hours, 48 hours, and 120 hours after thawing with use of the three methods. RESULTS: Thawing time for two units was 13.44 minutes using TT, the same as using BP at 37°C (12.94 min not prewarmed; 12.20 min prewarmed) or 45°C (12.38 min not prewarmed), but longer than using BP prewarmed to 45°C (11.31 min, p < 0.001). Thawing time for four units was 13.41 minutes using TT, shorter than using BP at 37°C (17.19 min not prewarmed, 18.47 min prewarmed; both p < 0.001) or 45°C (15.03 min not prewarmed, p = 0.012; 15.22 min prewarmed, p = 0.004). There was no reduction in hemostatic markers in LG-Octaplas with use of BP at 37°C or 45°C compared to TT. CONCLUSION: BP is quicker than TT by 2 minutes when thawing two units of FFP if it is prewarmed to 45°C. BP is slower than TT by at least 2 minutes when thawing four units of FFP at 37o C. There was no significant difference in the hemostatic qualities of plasma whether thawed at 37°C or 45°C.