title: Risk of Venous Thromboembolism After Receiving Prothrombin Complex Concentrate for Warfarin-associated Intracranial Hemorrhage.
abstract: BACKGROUND
  Prothrombin complex concentrates (PCCs) are commonly used to rapidly reverse warfarin-associated coagulopathy; however, venous thromboembolism (VTE) is an established adverse event.
  
  
  OBJECTIVE
  To determine risk factors for VTE AFTER administration of a three-factor prothrombin complex concentrate (3F-PCC) for warfarin-associated intracranial hemorrhage (ICH).
  
  
  METHODS
  Retrospective chart review of all patients with a warfarin-associated ICH who received a 3F-PCC at a single tertiary care hospital between 2008 and 2013. Outcomes were VTE events (defined as deep vein thrombosis [DVT], pulmonary embolism [PE], limb ischemia, transient ischemic attack, cerebrovascular accident, non-ST-segment elevation myocardial infarction, ST-segment elevation myocardial infarction, and unexplained sudden death) occurring within 30 days of 3F-PCC administration. Risk factors in subjects with and without VTE complications were compared via Fisher's exact test, Student's t-test, Mann-Whitney U test, and univariate logistic regression as appropriate.
  
  
  RESULTS
  Two hundred nine subjects received 3F-PCC for warfarin-associated ICH. There were 22 VTE events in 19 subjects (9.1%). Baseline characteristics of subjects with and without VTE were similar. There was a significant increase in VTE events in 29 subjects who were taking warfarin for a previous PE or DVT (36.8% vs. 11.6%, p = 0.007; logistic regression odds ratio 4.455, p = 0.005).
  
  
  CONCLUSIONS
  Patients with a prior history of PE or DVT who were given 3F-PCC for warfarin-associated ICH were 4.5 times more likely to sustain a VTE within 30 days. A careful analysis of risks and benefits of rapidly reversing anticoagulation must be made prior to the administration of 3F-PCC in this patient population.
authors.affiliation: Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
authors.forename: Diana
authors.initials: D
authors.lastname: Felton
authors.affiliation: Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Foley
authors.affiliation: Department of Emergency Medicine, Mayo Clinic Hospital, Phoenix, Arizona.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Traub
authors.affiliation: Department of Public Health, Ben Gurion University of the Negev, Soroka Clinical Research Center, Soroka University Medical Center, Beersheba, Israel.
authors.forename: Alina
authors.initials: A
authors.lastname: Vodonos
authors.affiliation: Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
authors.forename: Michael
authors.initials: M
authors.lastname: Ganetsky
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects*; D001779:Blood Coagulation Factors / Q000008:administration & dosage / Q000009:adverse effects*; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D020300:Intracranial Hemorrhages / Q000139:chemically induced* / Q000188:drug therapy*; D016015:Logistic Models; D008297:Male; D011655:Pulmonary Embolism / Q000188:drug therapy; D012189:Retrospective Studies; D012307:Risk Factors; D054556:Venous Thromboembolism / Q000209:etiology*; D020246:Venous Thrombosis / Q000188:drug therapy; D014859:Warfarin / Q000009:adverse effects*
chemical_list: D000925:Anticoagulants; D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates; D014859:Warfarin
keywords: PCC; Profilnine; intracranial hemorrhage; venous thromboembolism; warfarin