Prospective study of continuous infusion with Beriate® P in patients with severe haemophilia A undergoing surgery - a subgroup analysis

Abstract

Introduction: Inhibitor development in severe haemophilia A patients is currently the most serious complication of factor VIII (FVIII) treatment. Although continuous infusion (CI) of FVIII concentrate during surgical procedures in haemophilia A patients has been shown to be beneficial, some publications suggest that CI increases the risk of inhibitor generation. We conducted a prospective subgroup analysis to investigate if CI of the high-purity, pasteurized, plasma-derived FVIII concentrate Beriate(®) P during surgery increases the risk of inhibitor formation.

Materials and methods: Patients with severe haemophilia A (FVIII:C <1%) were included if they presented with a negative history of previous inhibitors, had ≥ 50 exposure days, and had been scheduled for a planned surgical procedure. A bolus infusion (30-50 IU/kg body weight) of Beriate(®) P was administered intravenously and followed by CI at a rate of 3-4 IU/kg body weight/hour. Dose adjustments were subsequently made based on daily measurements of plasma FVIII activity.

Results: Five patients (aged 8-34 years) with severe haemophilia A were included. The surgical procedures ranged from teeth extraction to internal fixation of a fracture. There was no inhibitor generation with CI of Beriate(®) P in patients undergoing surgery, and we did not observe any complications due to re-bleeding or virus transmission.

Conclusion: Beriate(®) P was efficacious, safe, and well tolerated during CI.

Keywords: Beriate(®) P; Coagulation disorders; Continuous infusion; Haemophilia A; Inhibitors; Surgery.