title: Prothrombinex-VF use in warfarin reversal and other indications.
abstract: OBJECTIVE
  To assess the use of Prothrombinex-VF powder for injection (PTX-VF) at Royal Perth Hospital and analyse the efficacy and safety profile of PTX-VF.
  
  
  METHODS
  A prospective observational audit of PTX-VF use, conducted by reviewing medical records and laboratory and imaging results for all patients prescribed PTX-VF from 1 November 2009 to 1 May 2010.
  
  
  METHODS
  Data on indication, diagnosis, comorbidities, dose of PTX-VF, fresh frozen plasma (FFP) and vitamin K, coagulation parameters before and after PTX-VF administration, and adverse effects.
  
  
  RESULTS
  334 vials of PTX-VF were administered to 84 patients over 107 prescriptions. Indications were warfarin reversal, intraoperative bleeding and coagulopathy (66, 20 and 21 prescriptions, respectively). PTX-VF with FFP was compared with PTX-VF alone for warfarin reversal and there was a significant decrease in international normalised ratio (INR) that was independent of group (P < 0.001). Lower doses of PTX-VF (< 25 IU/kg) were compared with higher doses (25-50 IU/kg) for warfarin reversal and decrease in INR was significant, independent of group (P = 0.002). PTX-VF was administered for intraoperative bleeding in 18 patients who had not been treated with warfarin. No hypersensitivity reactions, thrombotic complications or worsening of disseminated intravascular coagulation occurred during 7-day follow-up.
  
  
  CONCLUSIONS
  For warfarin reversal, lower doses of PTX-VF (< 25 IU/kg) and PTX-VF without FFP were effective. PTX-VF was also used in intraoperative bleeding and non-warfarin coagulopathy. No adverse events were associated with PTX-VF.
authors.affiliation: Department of Haematology, Fremantle Hospital and Health Service, Fremantle, WA. Paul.Kruger@health.wa.gov.au
authors.forename: Paul C
authors.initials: PC
authors.lastname: Kruger
authors.forename: Annette S
authors.initials: AS
authors.lastname: Le Viellez
authors.forename: Richard P
authors.initials: RP
authors.lastname: Herrmann
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D001779:Blood Coagulation Factors / Q000008:administration & dosage*; D016063:Blood Loss, Surgical / Q000517:prevention & control; D005260:Female; D006470:Hemorrhage / Q000517:prevention & control; D006801:Humans; D007267:Injections; D019934:International Normalized Ratio; D008297:Male; D008875:Middle Aged; D010949:Plasma; D014859:Warfarin / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates; D014859:Warfarin