Convenience Comparison Study of Reconstitution Devices for the Blood Coagulation Factor VIII Products Rurioctocog Alfa Pegol and Antihemophilic Factor (Recombinant).

Introduction: The Baxject II Hi-Flow device has previously been used to reconstitute the factor VIII products antihemophilic factor (recombinant) (ADVATE) and rurioctocog alfa pegol (ADYNOVATE).

Methods: In this crossover study in healthy men, the convenience of an advanced device, Baxject III with and without a nonslip sleeve, was compared with that of Baxject II Hi-Flow. The primary endpoint was the operational time for reconstitution; secondary endpoints included participants' assessment of the usability of the devices for reconstitution and their preference for using each of the devices.