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

Authors: Aouifi, A., Charbonnel, J. F., Lapeyre, E., Frebault, V., Pasquié M., Martel, A., Cornillot, C., Crave, J. C., Mayeur, N., and Charbonneau, H.

Publication: Journal of Cardiothoracic and Vascular Anesthesia; 34, S44-S45. November 2020

Affiliations : Unité de soins intensifs, Infirmerie Protestante, Caluire et Cuire, France; Service Pharmacie, Infirmerie Protestante, Caluire et Cuire, France; Recherche Clinique Infirmerie Protestante, Caluire et Cuire, France; Service Pharmacie, Clinique Pasteur, Toulouse, France; Service Pharmacie ,Clinique Pasteur, Toulouse, France; Direction Médicale Octapharma France, Boulogne-Billancourt, France; Département d’Anesthésie et Réanimation, Clinique Pasteur, Toulouse, France

Abstract: 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.