Universal use of PI was implemented without impacting component use, as indicated by total dose of PLTs per patient, and outcomes to transfusion were improved.
PCT-plasma transfusions were well tolerated in routine clinical use. The EDCS HV program facilitated collection and reporting of safety information on a real-time basis from multiple sites.
Process validation studies in three European centers demonstrated retention of coagulation factors in PCT-FFP within the required European and respective national standards for therapeutic plasma.
BACKGROUND
Liver transplant may require large‐volume plasma transfusion with increased risk of transfusion‐transmitted infection (TTI). Pathogen inactivation of plasma with amotosalen‐UVA offers the potential to mitigate TTI risk.
STUDY DESIGN AND METHODS
A retrospective cohort design was used to compare the therapeutic efficacy and key safety outcomes for liver transplants supported with quarantine plasma (Q‐FFP [reference]) or amotosalen‐UVA plasma (IBS plasma [test]). The outcomes evaluated were volume of plasma, the numbers of red blood cell (RBC) components, and the total dose of platelets (PLTs) transfused during and 7 days after transplant. The safety outcomes were acute hepatic artery thrombosis (HAT) and mortality.
RESULTS
Transplantation and transfusion records for 212 Q‐FFP transplants and 215 IBS plasma transplants were reviewed. Not all transplants required plasma; 161 received Q‐FFP and 174 received IBS plasma. Among the transplants that required plasma, there were significant differences in median values between cohorts for delay to transplantation (p = 0.002), model end‐stage liver disease score (p < 0.001), pretransplant hematocrit (p = 0.006), and graft cold perfusion time (p = 0.033). The median volumes of plasma transfused were not different for test and reference (2.160 L vs. 1.969 L, p = 0.292). Transplants in the test cohort required a mean of 3.7% more RBC components (p = 0.767) and on average a 16.5% increase in total PLT dose (p = 0.518). No significant differences were observed for the frequency of acute HAT or mortality.
CONCLUSION
In this retrospective study, IBS plasma provided therapeutic support of liver transplant not different from Q‐FFP.
BACKGROUND
Among labile blood products, platelet concentrates (PCs) are the leading cause of hypersensitivity transfusion reactions (HTRs). These reactions often lead to interruption of PC transfusion and can result in a prolonged transfusion process leading to significant morbidity and use of premedication and close monitoring for patients with a history of allergic transfusion reactions. The French hemovigilance database is one of the largest standardized databases providing information on HTRs following administration of labile blood products. In this study, we analyzed this database to assess the relative risk of HTR for each type of PC.
STUDY DESIGN AND METHODS
HTRs following PC transfusion were retrospectively extracted from the e‐Fit Hemovigilance database of the French National Agency for Medicines and Health Products Safety (ANSM). Frequencies were calculated using the number of specific PCs transfused.
RESULTS
Between 2008 and 2014, the overall estimated incidence of HTRs following PC administration was calculated at 232 HTRs per 100,000 PCs transfused. The rate of HTRs was significantly higher with apheresis PC (337/100,000) than with buffy‐coat PC (94/100,000). Platelets in additive solutions (PAS) were associated with a significantly lower frequency of HTRs when compared with PCs in native plasma. Amotosalen/UVA‐ PCs (APCs and BCPCs) which are always in PAS in France, exhibited the lowest frequency of HTRs when compared with their corresponding PCs in native plasma or in PAS (p < 10−7 in all comparisons).
CONCLUSION
Our results showed that the type of PC and its processing may have an impact on the risk of HTR.
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