Continuous infusion of B‐domain deleted recombinant factor VIII (ReFacto) in patients with haemophilia A undergoing surgery: clinical experience
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Summary. This retrospective, open‐label, non‐comparative study evaluated continuous infusion of recombinant factor VIII (ReFacto®), B‐domain deleted recombinant FVIII (BDDrFVIII), in patients with haemophilia A undergoing surgery and requiring >5 consecutive days of treatment. Sixteen patients from eight centres underwent a total of 20 procedures. Haemostatic outcome was assessed as ‘excellent’ or ‘good’ in 75% of procedures, and target FVIII:C levels were maintained throughout the continuous infusion period. The reported volume of blood loss during surgery was also within the normal range for non‐haemophilic patients for the type of surgery performed. Red blood cell transfusions were required to balance excessive blood loss during BDDrFVIII continuous infusion in eight (40%) procedures (seven patients), five with bleeding or requiring volume replacement and three to treat anaemia secondary to blood loss. Non‐serious adverse events considered by investigators as possibly or probably related to BDDrFVIII continuous infusion were infrequent (n = 5) considering the duration of treatment (n =239 cumulative days of continuous infusion), and all of these were mild‐to‐moderate in severity. No thromboembolic complications were reported except for one case of thrombophlebitis occurring at the infusion site. Only two patients (four events) experienced serious adverse bleeding; BDDrFVIII was otherwise well‐tolerated. These data show that continuous infusion of BDDrFVIII provides reliable haemostasis and is an effective and well‐tolerated regimen for patients with haemophilia A undergoing surgery.
