title: Prospective study of continuous infusion with Beriate® P in patients with severe haemophilia A undergoing surgery - a subgroup analysis.
abstract: BACKGROUND
  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.
  
  
  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.
  
  
  CONCLUSIONS
  Beriate(®) P was efficacious, safe, and well tolerated during CI.
authors.affiliation: Centre for Thrombosis and Haemostasis, Professor-Hess-Kinderklinik, Klinikum Bremen-Mitte, Bremen, Germany. Electronic address: GuenterAuerswald@aol.com.
authors.forename: Günter
authors.initials: G
authors.lastname: Auerswald
authors.affiliation: Centre for Thrombosis and Haemostasis, Professor-Hess-Kinderklinik, Klinikum Bremen-Mitte, Bremen, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Bade
authors.affiliation: Centre for Thrombosis and Haemostasis, Professor-Hess-Kinderklinik, Klinikum Bremen-Mitte, Bremen, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Johne
authors.affiliation: Centre for Thrombosis and Haemostasis, Professor-Hess-Kinderklinik, Klinikum Bremen-Mitte, Bremen, Germany.
authors.forename: Kirstin
authors.initials: K
authors.lastname: Haubold
authors.affiliation: Centre for Thrombosis and Haemostasis, Professor-Hess-Kinderklinik, Klinikum Bremen-Mitte, Bremen, Germany.
authors.forename: David
authors.initials: D
authors.lastname: Overberg
authors.affiliation: Centre for Thrombosis and Haemostasis, Professor-Hess-Kinderklinik, Klinikum Bremen-Mitte, Bremen, Germany.
authors.forename: Sylvia
authors.initials: S
authors.lastname: Masurat
authors.affiliation: Centre for Thrombosis and Haemostasis, Professor-Hess-Kinderklinik, Klinikum Bremen-Mitte, Bremen, Germany.
authors.forename: Carolin
authors.initials: C
authors.lastname: Moorthi
mesh_terms: D061605:Administration, Intravenous; D000293:Adolescent; D000328:Adult; D058731:Blood Safety; D002648:Child; D005167:Factor VII / Q000008:administration & dosage / Q000037:antagonists & inhibitors / Q000627:therapeutic use*; D005260:Female; D006467:Hemophilia A / Q000150:complications* / Q000601:surgery / Q000628:therapy*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D005167:Factor VII
keywords: Beriate(®) P; Coagulation disorders; Continuous infusion; Haemophilia A; Inhibitors; Surgery