Low Incidence of Hyperfibrinolysis and Thromboembolism in 195 Primary Liver Transplantations Transfused with Solvent/Detergent-Treated Plasma

Abstract

pathogen inactivation, the SD treatment secures pathogen reduction. [2][3][4] Due to dilution and possible neutralization of the responsible antibodies, SD-plasma has a markedly lower rate of allergic/immunologic reactions including no reported cases of transfusion related acute lung injury (TRALI) despite over 10 million units transfused. 5,6 Further, SD-plasma can be regarded as a biopharmaceutical product with Si gnificant perioperative bleeding and transfusions of plasma, red blood cells (RBCs), and platelets are considered part of the normal clinical course of orthotopic liver transplantation (OLT).1 By far the two most common plasma products available today are fresh frozen plasma (FFP) from single blood donors and solvent/detergent (SD)-treated pooled plasma. Whereas FFP does not undergo any kind of Background: Liver transplantation regularly requires transfusion of red blood cells (RBCs), plasma, and platelets. Compared to fresh frozen plasma (FFP) from single blood donors, solvent/detergent-treated plasma (SD-plasma) pooled from several hundred blood donors has advantages with respect to pathogen reduction, standardized content of plasma proteins, and significantly reduced risk of transfusion related lung injury and allergic/ immunologic adverse reactions. However, SD-plasma has been suspected to increase the incidence of hyperfibrinolysis and thromboembolic events. Study Design and Methods:We investigated the transfusion practices, hyperfibrinolysis parameters, and thrombosis outcomes in 195 consecutive adult primary liver transplants in our center using SD-plasma (Octaplas) as the exclusive source of plasma.Results: Perioperatively, median (interquartile range) 4 (1 to 9) RBC-units, 10 (4 to 18) plasma-bags, and 0 (0 to 2) platelet-units were transfused. Hyperfibrinolysis defined as LY30 ≤ 7.5% was detected in 12/138 thrombelastography-monitored patients (9%). These patients received significantly more RBCs, plasma, and platelets than did patients without hyperfibrinolysis. Thrombotic graft complications were observed in three patients (2%). Pulmonary embolism was not observed in any patient. Conclusion:SD-plasma is a safe plasma product for liver transplant recipients, and the incidences of hyperfibrinolysis and thromboembolic events are not significantly different from those seen in centers using FFP.

Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)

“…Use of large volumes (approx. 2 L) of Intercept plasma in liver transplantation yielded the same outcomes as with quarantine plasma . The current formulation of Octaplas has not been reported to be associated with thrombotic events when used in large volumes as had been seen with the original version of SD plasma …”

Solvent/detergent-treated plasma: a tale of 30 years of experience

“…Since 1993, in Norway, >250,000 units of S/D plasma have been successfully transfused to all categories of patients, including neonates and liver transplant recipients, with no cases of transmission of viral diseases, thrombotic complications or TRALI [38]. Moreover, a recent study by Haugaa et al shows that S/D plasma is a safe product for liver transplant recipients in whom the incidence of hyperfibrinolysis (9%) and thromboembolic events (2%) are not significantly different from those reported in centers using nonpathogen inactivated plasma [58]. In the UK, >350,000 units of S/D plasma have been transfused after the introduction of the Serious Hazards of Transfusion hemovigilance system without reports of serious adverse events [59].…”

Pathogen reduced plasma products: a clinical practice scientific review from the AABB

“…Synopsis: Fifteen observational trials and seven RCTs were used to evaluate the safety of S/D plasma. No study reported an increase in AE in S/D plasma compared to conventional plasma and most reported a decrease.…”

“…Three studies reported on hyperfibrinolytic episodes. One randomized controlled trial and one prospective observational study showed no difference with regard to the number of hyperfibrinolytic episodes and need for antifibrinolytic medications . In a comparison of cardiac surgery patients receiving either S/D or FFP, one study found decreased levels of PS and plasmin inhibitor in the S/D plasma cohort (first‐generation S/D product with longer S/D incubation time), but no difference in hyperfibrinolysis .…”

“…In a comparison of cardiac surgery patients receiving either S/D or FFP, one study found decreased levels of PS and plasmin inhibitor in the S/D plasma cohort (first‐generation S/D product with longer S/D incubation time), but no difference in hyperfibrinolysis . Four studies evaluated and found no evidence of complement activation …”