title: [Safety and efficacy of a prothrombin complex concentrate in patients with coagulopathy and hemorrhage].
abstract: BACKGROUND
  Prothrombin complex concentrates (PCC) are approved for urgent reversal of vitamin K antagonists (VKA). Recently, PCC have been used in the management of massive bleeding-associated coagulopathy. The present work evaluates safety and efficacy of PCC in a case series of both VKA reversal and massive bleeding.
  
  
  METHODS
  Retrospective review of cases treated with CCP (January 2010 to February 2013). Safety endpoints were infusion reactions and incidence of thromboembolic events. Efficacy endpoints were: 1) VKA reversal efficacy and 2) Massive bleeding coagulopathy reversal and 24h mortality.
  
  
  RESULTS
  Thirty-one patients were included (22 male), median age 61 years (range 30-86). No infusion reactions were detected, and only 1 thrombotic episode was observed. VKA reversal was effective in 100% of patients (6/6), all of them with complete reversal of INR value. In massive bleeding, 24-hour survival was 64% (16/25). Invasive hemostatic procedures were required in 28% of patients (7/25). CCP use was correlated with bleeding control in 44% of cases (11/25), and also significantly associated with survival (p=0.01).
  
  
  CONCLUSIONS
  CCP are safe and effective for the novel indication of adjuvant treatment in massive bleeding patients, as well as for traditional urgent reversal of VKA.
authors.forename: N
authors.initials: N
authors.lastname: Martínez-Calle
authors.forename: M
authors.initials: M
authors.lastname: Marcos-Jubilar
authors.forename: A
authors.initials: A
authors.lastname: Alfonso
authors.forename: M
authors.initials: M
authors.lastname: Hernández
authors.forename: F
authors.initials: F
authors.lastname: Hidalgo
authors.forename: R
authors.initials: R
authors.lastname: Lecumberri
authors.affiliation: Servicio de Hematología y Hemoterapia, Clínica Universidad de Navarra, Pamplona, 31008, Spain. japaramo@unav.es.
authors.forename: Ja
authors.initials: J
authors.lastname: Páramo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001778:Blood Coagulation Disorders / Q000188:drug therapy*; D001779:Blood Coagulation Factors / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates