Safety and efficacy of high-purity concentrates in haemophiliac patients undergoing surgery by continuous infusion

In this study we explore the feasibility of high‐purity double‐inactivated concentrates by continuous infusion for the treatment of haemophiliacs in a group of patients undergoing different surgical procedures. The patients were enrolled in the study on the basis of their transfusion history, which was well known due to their long‐term follow up at our Haemophilia Center. We did not perform a pre‐operative pharmacokinetic study because one of the aims of this study was to demonstrate that continuous infusion can become a first choice standard treatment in patients with haemophilia. Fourteen haemophilia A and one haemophilia B patients who needed at least 5 days of replacement therapy were monitored for haemostatic efficacy, post‐operative factor VIII and factor IX levels and evaluated for safety and flexibility of the products. The infusion rate of 3 IU kg–1 h–1 was demonstrated to be sufficient to ensure haemostasis and patients did not need additional bolus infusion during the post‐operative period. Our study demonstrates the safety and feasibility of high‐purity concentrates in patients undergoing surgery by continuous infusion, also in the absence of a previous pharmacokinetic study.