Evaluation of solvent/detergent‐treated plasma safety and efficacy in orthotopic liver transplant and thrombotic thrombocytopenic purpura patients: A single center experience

Abstract

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)

Thirty years of experience with solvent/detergent‐treated plasma for transfusion medicine

“…Octaplas/octaplasLG efficacy has been demonstrated in adults for indications such as cardiac surgery, 25,43,47 coagulopathy resulting from liver disease and liver transplantation, 28,33,[38][39][40]42,48 hemodilution or blood loss, 38,49 TPE, 4,[50][51][52][53] as well as obstetric and gynecological complications (Table 3). 33 Real-world safety has also been evaluated by numerous clinical studies (Table 3) and extensive hemovigilance programs.…”