Comparative effectiveness of plasma prepared with amotosalen‐UVA pathogen inactivation and conventional plasma for support of liver transplantation

Abstract

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.

Patient outcomes and amotosalen/UVA‐treated platelet utilization in massively transfused patients

“…Our clinical observations reported here for amotosalen/UVA‐treated platelets in the MT setting argue strongly against this hypothesis and instead support the safety and efficacy of these components in patients requiring MT. Furthermore, the comparative effectiveness studies of amotosalen/UVA‐treated and conventional plasma in general liver transplantation, including those that required MT, similarly suggested that pathogen reduction in plasma did not adversely affect outcomes . While our study included only a small number of trauma patients, the high mortality in all non‐liver transplant patients with MT supports a similar haemorrhagic risk profile as is seen in trauma.…”

“…The low overall in‐hospital mortality rate [4/93 patients (4·3%)] despite the need for MT is reflective of the elective nature of liver transplant surgery, and speaks to the effectiveness of massive transfusion strategies that now include pathogen‐reduced PC. A similar study previously showed that plasma treated with the amotosalen/UVA process was equivalent to conventional plasma in the liver transplantation setting .…”

“…Amotosalen/UVA‐treated PCs have demonstrated efficacy for treatment and prevention of bleeding in large randomized controlled clinical trials . Efficacy and safety were confirmed under routine‐use conditions, as reported to large national haemovigilance programmes and in industry‐sponsored postmarketing comparative effectiveness studies .…”

“…Liver transplants are usually elective procedures in patients with an underlying coagulopathy related to liver dysfunction. While most liver transplants do not require MT , the major vascular anastomoses necessary and the unavoidable exacerbation of coagulopathy related to the anhepatic phase of transplantation surgery cause these patients to be at high risk of excessive bleeding. While plasma transfusion is critical to replace coagulation factors synthesized in the liver, platelets also play an important role in achieving haemostasis.…”

Update on pathogen inactivation treatment of plasma, with the INTERCEPT Blood System: Current position on methodological, clinical and regulatory aspects

“…Additional, larger phase IV retrospective clinical studies have been successfully performed in the TTP and liver transplantation settings [23,24]. The set of clinical trials performed encompasses most of the routine applications for INTERCEPT treated plasma.…”