title: Safety and efficacy of BAY 81-8973 for surgery in previously treated patients with haemophilia A: results of the LEOPOLD clinical trial programme.
abstract: BACKGROUND
  BAY 81-8973 is a recombinant factor VIII (rFVIII) with the same amino acid sequence as Bayer's sucrose-formulated rFVIII (rFVIII-FS) but manufactured with certain more advanced technologies.
  
  
  OBJECTIVE
  To describe surgery outcomes with BAY 81-8973 in the LEOPOLD trials.
  
  
  METHODS
  Male patients with severe haemophilia A and no inhibitors aged 12-65 years with ≥150 exposure days (EDs) to FVIII (LEOPOLD I and II), or aged ≤12 years with ≥50 EDs to FVIII (LEOPOLD Kids), received BAY 81-8973 based on dosing recommendations for rFVIII-FS according to surgical requirements. Haemostasis-related complications, investigator/surgeon assessment of haemostasis, blood loss, need for transfusion and use of BAY 81-8973 were determined.
  
  
  RESULTS
  In LEOPOLD I and II, 11 patients (mean age, 35.3 years) underwent 13 major surgeries. In LEOPOLD Kids, one patient (aged 6 years) underwent one major surgery. Thirty-two adult and paediatric patients underwent 46 minor surgeries. Haemostasis was rated good or excellent in all major and minor surgeries. Blood loss during surgery did not exceed expected amounts; blood transfusions were required in three of the 14 major surgeries. For major surgeries in LEOPOLD I and II, patients received a presurgical 50-IU kg(-1) dose of BAY 81-8973; median nominal dose on day of surgery was 7000 IU (107.5 IU kg(-1) ). Total BAY 81-8973 dose was 2500 IU (108.7 IU kg(-1) ) on the day of the only major surgery in LEOPOLD Kids. No haemostasis-related complications were reported.
  
  
  CONCLUSIONS
  Haemostatic control with BAY 81-8973 during all surgeries in the LEOPOLD trials was good or excellent, with no haemostasis-related complications.
authors.affiliation: University Clinic Bonn, Bonn, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Oldenburg
authors.affiliation: Institute of Hematology and Transfusion Medicine, Warsaw, Poland.
authors.forename: J
authors.initials: J
authors.lastname: Windyga
authors.affiliation: Sheffield Haemophilia and Thrombosis Center, Sheffield, UK.
authors.forename: K
authors.initials: K
authors.lastname: Hampton
authors.affiliation: National Hemophilia Center, Chaim Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: S
authors.initials: S
authors.lastname: Lalezari
authors.affiliation: Bayer Pharma AG, Berlin, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Tseneklidou-Stoeter
authors.affiliation: Bayer Pharma AG, Wuppertal, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Beckmann
authors.affiliation: Bayer Pharma AG, Wuppertal, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Maas Enriquez
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001803:Blood Transfusion; D002648:Child; D003029:Coagulants / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D018592:Cross-Over Studies; D005169:Factor VIII / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006467:Hemophilia A / Q000188:drug therapy* / Q000473:pathology; D006470:Hemorrhage / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D013514:Surgical Procedures, Operative; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003029:Coagulants; C078147:F8 protein, human; D005169:Factor VIII
keywords: children; clinical trial; haemophilia A; haemostasis; recombinant FVIII; surgery