Five‐day stability of thawed plasma: solvent/detergent‐treated plasma comparable with fresh‐frozen plasma and plasma frozen within 24 hours

Abstract

BACKGROUND Plasma stored refrigerated for up to 5 days after thawing is common practice in many US hospitals. Therefore, clotting factor activities in fresh‐frozen plasma (FFP), plasma frozen within 24 hours (PF24), and solvent/detergent‐treated plasma (SDP), thawed and stored at 1 to 6°C for up to 5 days, were investigated. STUDY DESIGN AND METHODS Five A, B, O, and AB units of FFP, PF24, and SDP were thawed and maintained for 5 days at 1 to 6°C. The activity of factor (F)V, FVII, FVIII, protein S (PS), and ADAMTS13 was determined in each unit at baseline and every 24 hours thereafter for 5 days. RESULTS After thaw, mean values of the variables tested were within the normal range in all three plasma products although, in SDP, FVIII activity was significantly lower (p = 0.0039). After 5 days of storage all factors significantly declined except for ADAMTS13 activity, which was stable. Mean FVIII and ADAMTS13 activity was comparable in all three plasma products and within the normal range, mean FV activity was significantly lower in FFP and PF24 (p<0.0001) compared to SDP, and mean FVII activity was significantly lower in PF24 (p<0.03) than in FFP or SDP. Mean PS activity was below the normal range in all three plasma products with the lowest values in SDP (p = 0.0001). CONCLUSION Over 5 days of refrigerated storage the changes in the measured coagulation factors in FFP, PF24, and SDP are comparable. Clinical follow‐up is needed to assess whether slightly lower PS levels in SDP are clinically important.

Stability of Thawed Apheresis Fresh-Frozen Plasma Stored for up to 120 Hours at 1°C to 6°C

“…Sidhu et al also found no change in fibrinogen or FVII levels between Days 1 and 5 of refrigerated storage and a statistically significant loss of FV activity, mirroring our results [23]. Similarly, Neisser-Svae et al found residual FVIII activities in thawed FFP of 0.75 ± 0.13 IU/mL (mean ± SD) after 5 days of refrigerated storage [24], and von Heymann et al reported median FVIII values of 0.75 with an interquartile (25–75%) range of 0.68 to 0.88 IU/mL for thawed FFP, again showing strong similarity to our results with ACD-FFPA [25]. …”

Comment on: Addendum to the British Committee for Standards in Haematology (BCSH): Guidelines for the use of fresh‐frozen plasma, cryoprecipitate and cryosupernatant, 2004 (Br. J Haematol 2004,126,11‐28)

“…We thank Neisser-Svae and Heger for their interest in the addendum publication (Green et al, 2017), and for sharing their data of thawed solvent detergent-treated fresh frozen plasma (SDFFP) for up to 5 days (Neisser-Svae et al, 2016). We agree with the authors that the reduction in factor VIII (FVIII) for 5 days following thawing is not significantly different between SDFFP and fresh frozen plasma (FFP).…”

“…Although the solvent/detergent (S/D) treated FFP (Octaplas) is not considered in this addendum, we would like to bring to the readers' attention that a 5-day stability study comparing Octaplas to FFP has recently been published (Neisser-Svae et al, 2016). In this study, in addition to the activity level of factor (F)V and FVII, the change in the activity of the procoagulant labile FVIII during storage was investigated.…”

Management of intracranial hemorrhage in severe factor V deficiency and definitive treatment with liver transplantation

“…After thawing, FV activity in FFP decreases from 1.11 ± 0.22 IU/mL on Day 0 to 0.66 ± 0.15 IU/mL on Day 5, representing a 40% decrease. When SDP is thawed, FV activity decreases from 1.20 ± 0.14 IU/mL on Day 0 to 0.85 ± 0.06 IU/mL, representing only a 29% decrease …”