First open label study to investigate the use, safety and tolerability of octaplaslg® in patient blood management in two cardiac surgery centres in France

Introduction Fresh Frozen Plasma (FFP) is used to correct haemostatic function after cardiac surgery with cardio-pulmonary bypass (CPB). As a blood product, availability of FFP can be challenging. OctaplasLG®, a solvent/detergent (SD) treated and pooled human plasma, has been recently introduced in France. As a drug, it is delivered by hospital pharmacists. The main objective of this study was to describe the use of OctaplasLG® infusion in cardiac surgery patients. Feasibility, safety and drug tolerability of OctaplasLG® were assessed by monitoring Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs) like allergic reaction, transfusion related acute lung injury (TRALI) events or transmitted transfusion diseases during 24 hours following each administration. Methods This observational and prospective study was conducted in 2 main French cardiac surgery centres from 27-Feb-2019 to 24-Feb-2020. All patients included in this study received OctaplasLG® because of abnormal peri-operative blood loss or haemostatic disorders in the peri-operative settings of cardio-vascular surgery. Data collected and analysed were demographic characteristic of patients, indications modalities, efficacy and safety outcomes of OctaplasLG® infusions. Results 99 adult patients were included, mean age 68.9 ± 11.6 years (67% male). OctaplasLG® indications were coagulopathy (70 %) and moderate haemorrhage (30%). OctaplasLG® was used 70% in the operating room and 30% in the intensive care unit (ICU). Cardiac surgery with CPB was performed in 83 patients. Infusion was done through a central venous line in 80% of patients. Emergency level of infusion was defined by physicians as immediate vital emergency, vital emergency, relative emergency and planned intervention for 24%, 38%, 32% and 5% respectively. Mean ± SD total dose of OctaplasLG® infused per patient was 2.9 ± 1.7 units (median 3 units of 200 ml). In addition to OctaplasLG®, patients received red blood cells (52%), platelets (37%) and fibrinogen concentrate (44%). No ADRs was reported during the 24h follow-up period. Six SAE were reported but not related to OctaplasLG®, 5 of which had a fatal outcome. OctaplasLG® infusion was evaluated as successful in 97 % of cases by investigators. Discussion Cardiac surgery is associated with a substantial risk of bleeding, frequently requiring the administration of FFP. In this descriptive study, the use of OctaplasLG®, a SD treated plasma, as a new drug for haemostatic disorders following cardio-vascular surgery seems feasible, readily available, safe and effective.