Background: Solvent/detergent-treated, pooled plasma (SDP) is approved for use in orthotopic liver transplantation (OLT) and thrombotic thrombocytopenic purpura (TTP) patients; however, studies evaluating safety and effectiveness of SDP in these populations are limited. Methods: This prospective study included two cohorts: OLT patients (n = 40) who received either SDP (n = 20) or FFP (control group) (n = 20), and TTP patients (n = 20) who received either SDP (n = 10) or FFP (control group) (n = 10) throughout hospitalization. Medical, laboratory, and blood bank records were retroactively assessed for both cohorts for differences in clinical outcomes, laboratory values, and transfusion data from admission to discharge.Results: In the OLT cohort, significant changes in AST and ALP were observed in the control group as compared to SDP (p < .05 each), and creatinine levels improved significantly in the SDP group as compared to the control group (p < .05) from admission to discharge. In the TTP cohort, platelet counts were significantly improved within the control and SDP groups from admission to discharge, but there were no significant differences between groups (p = .31). LDH levels improved between admission and discharge for both groups (70% decrease in the control group, p < .001, and 80% decrease in the SDP group, p = .001). There were no significant differences detected in clinical outcomes in either cohort. Conclusions: As evidenced by the lack of adverse events in either cohort and similar clinical outcomes, we conclude that SDP is comparable in safety and effectiveness to FFP in OLT and TTP patients. Further studies are needed to evaluate the potential for improved safety with SDP. K E Y W O R D Sapheresis, fresh frozen plasma (FFP), orthotopic liver transplant (OLT), plasma exchange, plasma transfusion, solvent/detergent plasma (SDP), thrombotic thrombocytopenic purpura (TTP)

Background : Plasma exchange is the primary treatment for acute episodes of Thrombotic Thrombocytopenic Purpura (TTP), a rare condition characterized by the formation of thromboses in small blood vessels, resulting in thrombocytopenia, hemolytic anemia and multi-organ failure. Plasma exchange replacement fluids in TTP include Fresh Frozen Plasma (FFP) and solvent/detergent treated pooled plasma (SDP), such as Octaplas. SDP is a virus-inactivated, pooled human plasma product with standardized plasma protein content, including ADAMTS13, that has been used in the treatment of TTP. This study evaluates the effectiveness of SDP as compared to FFP in the treatment of acute TTP episodes. Study Design and Methods : A retrospective analysis was conducted comparing SDP- to FFP-treated patients with suspected acute TTP episodes as a primary admitting diagnosis between December 2014 and December 2019. A total of 16 patients were included in this study. The FFP group consisted of 9 patients (6M/3F, median age 44 years), three of whom had relapsed TTP. The SDP cohort had 7 patients (2M/5F, median age 38 years), one of whom had relapsed TTP. The primary outcomes measured included reported thromboembolic and major bleeding events. Secondary outcomes included number of plasma exchange procedures, adverse effects including neurological changes, transfusion of other blood products, ICU and hospital length of stay (LOS), and changes in laboratory values. Results : There were no adverse transfusion reactions reported in either group. 12 bleeding events were reported from 6 patients in the FFP group and 8 bleeding events from 4 patients in the SDP group (p=0.397). No significant differences were detected in ICU stay, hospital LOS, number of plasma units transfused, daily percentage of change of laboratory values, or changes in neurological status. Conclusions:These data confirm the previously reported efficacy of SDP for treating suspected/confirmed TTP.There were no significant differences in thromboembolic or bleeding events between patients who received FFP as compared to SDP. The non-significant differences observed in laboratory values throughout the duration of plasma exchange procedures as well as adverse reactions and clinical outcomes between both groups confirm the safety of SDP when used interchangeably with FFP for the treatment of TTP. Table Disclosures Blumberg: CSL Behring: Consultancy. Refaai:CSL Behring: Consultancy; Octapharma: Research Funding; Instrumentation Laboratory: Research Funding; iLine Microsystems: Research Funding; Diagnostica Stago: Consultancy.