title: Clinical use of Haemate® P in von Willebrand disease: a 25-year retrospective observational study.
abstract: BACKGROUND
  von Willebrand disease (VWD) is caused by dysfunction or diminished levels of von Willebrand factor (VWF). VWF-containing plasma concentrates are used for treatment of patients with VWD for whom desmopressin treatment is insufficient or contraindicated. A single-centre, retrospective observational study over a period of up to 25 years was conducted to evaluate the effectiveness and safety profile of Haemate(®) P (CSL Behring, Marburg, Germany), a plasma-derived, purified, pasteurised and lyophilised VWF-containing factor VIII (FVIII) concentrate.
  
  
  METHODS
  The study included 71 patients who had been treated with Haemate(®) P over a period of > 5 years.
  
  
  RESULTS
  A total of 663 treatments with individual laboratory evaluations were recorded. Two patients had both mild type 1 VWD and haemophilia A (HA), three had HA only, 39 had type 1 VWD, 16 had type 2 VWD, nine had type 3 VWD, one had acquired VWD and one had uncategorised VWD. Haemate(®) P treatment indications included bleeding events (37 patients) and surgical interventions (70 patients). Thirteen patients received Haemate(®) P as long-term prophylaxis (n = 3), as part of rehabilitation treatment (n = 5), or in context of recovery measurements (n = 5). Treatment with Haemate(®) P was generally well tolerated; only one thromboembolic event occurred. In cases of bleeding events, Haemate(®) P was haemostatically effective in all patients. Furthermore, during operations where Haemate(®) P was administered, >90% incurred no complications.
  
  
  CONCLUSIONS
  In this retrospective observational study, Haemate(®) P was shown to be effective and safe for the treatment of VWD in adult patients.
authors.affiliation: University Hospital Frankfurt Haemophilia Centre, Medical Clinic III, Institute of Immunohaematology and Transfusion Medicine, Theodor-Stern-Kai 7, 60596 Frankfurt, Germany. Electronic address: Wolfgang.Miesbach@kgu.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Miesbach
authors.affiliation: University Hospital Frankfurt Haemophilia Centre, Medical Clinic III, Institute of Immunohaematology and Transfusion Medicine, Theodor-Stern-Kai 7, 60596 Frankfurt, Germany.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Krekeler
authors.affiliation: University Hospital Frankfurt Haemophilia Centre, Medical Clinic III, Institute of Immunohaematology and Transfusion Medicine, Theodor-Stern-Kai 7, 60596 Frankfurt, Germany.
authors.forename: Zsuzsanna
authors.initials: Z
authors.lastname: Wolf
authors.affiliation: Institute of Immunohaematology and Transfusion Medicine, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60596 Frankfurt, Germany.
authors.forename: Erhard
authors.initials: E
authors.lastname: Seifried
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004338:Drug Combinations; D005169:Factor VIII / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D006490:Hemostatics / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D014842:von Willebrand Diseases / Q000188:drug therapy*; D014841:von Willebrand Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*
chemical_list: D004338:Drug Combinations; D006490:Hemostatics; C509423:factor VIII, von Willebrand factor drug combination; D014841:von Willebrand Factor; D005169:Factor VIII
keywords: Factor VIII; Haemate; Haemophilia A; Humate; von Willebrand disease; von Willebrand factor