Medical Director of Apheresis Mayo Clinic Hospital Phoenix, Arizona, United States
Background/Case Studies: Thawed plasma (TP) is routinely stored for up to five days at 1–6°C post-thaw, while Octaplas, a solvent/detergent-treated pooled plasma product, is currently limited to 24 hours. Given Octaplas’ standardized manufacturing process and pooled donor source, its baseline factor levels are expected to be more uniform than TP. However, little published data exists comparing the post-thaw stability and predictability of degradation of key coagulation proteins between these products over extended storage. This study evaluated the degradation and variability of fibrinogen, Factor II (F2), and Factor VII (F7) over five days of refrigeration in Octaplas versus TP.
Study
Design/Methods: Five units each of TP and Octaplas were thawed and stored at 1–6°C. Daily samples were drawn for five days (Day 1 to Day 5) and tested within one hour for fibrinogen, F2, and F7 levels using standard coagulation assays. Degradation was calculated as the percentage change from Day 1 for each factor in each unit. Intra-product variability was assessed by standard deviation of degradation values across all units.
Results/Findings: On average, degradation from Day 1 to Day 5 in TP was:
Fibrinogen: −13.6% (SD 4.9%)
Factor II: −11.2% (SD 4.0%)
Factor VII: −32.2% (SD 4.2%)
In contrast, Octaplas demonstrated:
Fibrinogen: −14.5% (SD 4.5%)
Factor II: −9.6% (SD 2.1%)
Factor VII: −11.4% (SD 2.9%)
While fibrinogen degradation was similar between products, Octaplas preserved Factor VII significantly better and more consistently than TP, and Factor II also showed lower variability. These findings align with the anticipated uniformity conferred by Octaplas' pooled and standardized nature.
Conclusions: Octaplas demonstrated equivalent or superior stability in all evaluated factors over five days of refrigeration, with notably lower inter-unit variability in Factor II and VII degradation compared to TP. Given these results, the current 24-hour post-thaw limitation on Octaplas appears overly conservative. This study supports consideration of a longer refrigerated shelf life for Octaplas, potentially up to five days. We recommend that the manufacturer pursue updated regulatory approval from the U.S. Food and Drug Administration (FDA) based on new stability data and clinical utility. Such an extension could reduce product waste, improve logistical flexibility, and better align Octaplas with existing thawed plasma practices.
