title: [Serious hemorrhages related to vitamin K antagonist treated by prothrombic complexes: retrospective study conducted in 2008].
abstract: OBJECTIVE
  Vitamin K antagonist are widely used and clearly useful in the prevention of thrombotic and embolic events. However, they expose to hemorrhagic risk. The aim of this retrospective study was to describe the serious hemorrhagic events that occurred in patients treated with vitamin K antagonist and that required administration of prothrombotic complexes concentrates.
  
  
  METHODS
  A comparative analysis of the file of the central pharmacy (that dispensed the prothrombotic complexes concentrates) and patient data of the department of medical information was perform to ascertain the population of patients having received some prothrombotic complexes concentrates. Then, hospitalization reports were consulted to select the patients having presented a severe bleeding while receveiving vitamin K antagonist. We collected patients' characteristics, bleeding location, INR values, emergency care, seriousness and medical issue. Imputability was determined with the French method of pharmacovigilance.
  
  
  RESULTS
  In 2008, in Caen University hospital, 80 patients received prothrombotic complexes concentrates in the context of a serious hemorrhage due to vitamin K antagonist. Their mean age was 75years and the most common presentation was a neurological hemorrhage (38,7%). For 63,8% of the patients, there was an overdose in vitamin K antagonist. Twenty-two patients died during their hospitalization and 10 others presented later sequelas. None of the patients included in this study had been spontaneously declared to the pharmacovigilance. High imputability scores were positively correlated with INR (P=0.0002).
  
  
  CONCLUSIONS
  Quality of emergency care of hemorrhagic events due to vitamin K antagonist could be improved with a better application of the professional recommendations and a spontaneous declaration to pharmacovigilance.
authors.affiliation: Département d'Information Médicale, CHU Côte-de-Nacre, Avenue de la Côte-de-Nacre, BP 95182, 14033 Caen cedex 9, France. emeline.duroy@gmail.com
authors.forename: E
authors.initials: E
authors.lastname: Duroy
authors.forename: B
authors.initials: B
authors.lastname: de la Gastine
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001779:Blood Coagulation Factors / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012720:Severity of Illness Index; D014812:Vitamin K / Q000037:antagonists & inhibitors*
chemical_list: D001779:Blood Coagulation Factors; D014812:Vitamin K; C025667:prothrombin complex concentrates