Efficacy and safety of plasma exchange using a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma for the treatment of thrombotic microangiopathy: The first French experience in a single center

Abstract

Background: Octaplas LG® is the first plasma with marketing authorisation, available in France only since February 2016. This is a double viral inactivated and prion reduced solvent/detergent fresh frozen plasma. Clinical data on Octaplas LG® use in thrombotic microangiopathy (TMA) remains very limited. In May 2017, we were the first hospital in France to benefit of this new plasma product now dispensed by hospital pharmacies. We present a prospective review of all therapeutic plasma exchange (TPE) procedures for TMA patients in our hospital to evaluate the new delivery circuit, the efficacy and the adverse events (AE) related to this plasma.

Study design and methods: We prospectively reviewed 166 TPE procedures where Octaplas LG® was used as replacement fluid in 15 consecutive TMA patients required TPE in our hospital from May 2017 until December 2018.

Results: The total replacement plasma volume administered was 763 L (3818 units) with a median on 32 L (range 6-157) per episode. Remission was achieved in all cases after a median of 7 TPE per patient's episode. No exacerbation nor relapse were noted. One patient presented a grade 1 citrate reaction, and another patient an allergic reaction. We deplored pulmonary embolism in 2 patients.

Conclusion: In our experience OctaplasLG® was well-tolerated and was effective at inducing a full clinical remission. Although two PE were noted, the relationship to OctaplasLG® in unclear. The new dispensing circuit through the hospital pharmacy has proven to be safe and efficient.

Keywords: Octaplas LG®; Plasma exchange; Safety; Solvent detergent plasma; Thrombotic microangiopathy; Thrombotic thrombocytopenic purpura.