A Pilot Study on the Replacement of Fibrinogen with Fibrinogen Concentrates During Therapeutic Plasma Exchange with...

Background: Therapeutic plasma exchange (TPE) removes coagulation factors and leads to depletion coagulopathy. The aim of the study was to compare hemostasis between TPE procedures without coagulation factor replacement (electrolyte group), the partial replacement of fibrinogen with fibrinogen concentrates (fibrinogen group) and partial coagulation factors replacement with fresh frozen plasma (partial FFP group). Methods: A total of 73 TPE procedures in patients with fibrinogen levels 1-2 g/L were divided into three study groups depending on clinically estimated bleeding risk. Standard coagulation and ROTEM^® tests were performed before and after TPE. Results: Fibrinogen levels before TPE (p = 0.88) and after TPE (p = 0.33) were comparable between the fibrinogen and partial FFP groups. INR and ROTEM^® parameters reflected moderately worse hemostasis after TPE with fibrinogen-only replacement compared to partial FFP replacement, which could result in increased bleeding risk. In the electrolyte group, most laboratory tests confirmed the most deranged hemostasis after TPE, as compared to fibrinogen or partial FFP replacement. A mild allergic reaction to FFP infusion was noted during one TPE. No clinically significant bleeding occurred in any of the study groups. Conclusions: Fibrinogen concentrate supplementation and partial FFP replacement can both maintain fibrinogen levels > 1 g/L after TPE, but modest differences in classical coagulation tests and bedside ROTEM^® tests favor FFP replacement (NCT03801135).