title: Prothrombin complex concentrate (Octaplex) in patients requiring immediate reversal of oral anticoagulation.
abstract: BACKGROUND
  Rapid reversal of anticoagulant effect from the use of vitamin K antagonists (VKA) is essential when acute bleeding or emergency surgery occurs. Prothrombin complex concentrates (PCCs) produce a more rapid effect with a better clinical outcome, and do not cause volume overload as compared with fresh-frozen plasma (FFP). Octaplex is a modern, double virus safeguarded PCC with balanced content of vitamin K-dependent coagulation factors, which ensures fast onset of action and efficacious treatment, i.e. rapid correction of international normalized ratio (INR).
  
  
  METHODS
  The main purpose of this study was to demonstrate that Octaplex, when individually dosed, efficiently corrects INR to pre-determined levels in patients under oral anticoagulation who have bleeding complications or are undergoing invasive procedures. To measure the efficacy response, the INR achieved after PCC application per patient was calculated as geometric mean of three measurements within 1 h post-infusion.
  
  
  RESULTS
  Sixty patients received a median total Octaplex dose of 41.1 (15.3-83.3) IU/kg body weight (bw). Of 56 patients evaluable in terms of efficacy, 51 (91%) showed a response as pre-defined in the protocol and in 52 (93%) the INR decreased to a value below 1.4 within one hour after dosing. The median INR declined from 2.8 (1.5-9.5) to 1.1 (1.0-1.9) within 10 min. All prothrombin complex coagulation factors recovered in parallel. Three patients had minor adverse drug reactions. One patient showed a non-symptomatic parvovirus B19 seroconversion. No thrombotic side effects were observed.
  
  
  CONCLUSIONS
  Octaplex is efficacious and safe in immediate correction of dosage-dependent INR in patients with VKA-related deficiency of prothrombin complex coagulation factors.
authors.affiliation: Department of Hematology and Oncology, Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum, Berlin, Germany.
authors.forename: Hanno B
authors.initials: HB
authors.lastname: Riess
authors.forename: Andreas
authors.initials: A
authors.lastname: Meier-Hellmann
authors.forename: Johann
authors.initials: J
authors.lastname: Motsch
authors.forename: Mazen
authors.initials: M
authors.lastname: Elias
authors.forename: Friedrich W
authors.initials: FW
authors.lastname: Kursten
authors.forename: Carl-Erik
authors.initials: CE
authors.lastname: Dempfle
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects*; D001779:Blood Coagulation Factors / Q000008:administration & dosage* / Q000494:pharmacology; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced* / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D011300:Preoperative Care / Q000379:methods; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors
chemical_list: D000925:Anticoagulants; D001779:Blood Coagulation Factors; D014812:Vitamin K; C025667:prothrombin complex concentrates