title: Failure to correct International Normalized Ratio and mortality among patients with warfarin-related major bleeding: an analysis of electronic health records.
abstract: BACKGROUND
  Delayed correction of blood clotting times as measured by the International Normalized Ratio (INR) is associated with adverse outcomes among certain patients with warfarin-related major bleeding. However, there are limited data on the association between INR correction and mortality.
  
  
  OBJECTIVE
  To assess factors associated with 30-day mortality and time to death in patients receiving fresh frozen plasma (FFP) for warfarin-associated major bleeding.
  
  
  METHODS
  A retrospective database analysis was undertaken with electronic health record data from a large integrated health system. Patients met the following criteria: major hemorrhage diagnosis; INR ≥ 2 on the day before or day of receipt of FFP; and prescription fill for warfarin within 90 days. INR correction (defined as INR ≤ 1.3) was evaluated at the last available test 1 day following the start of FFP administration. Kaplan-Meier curves and Cox proportional hazards models were constructed to assess mortality.
  
  
  RESULTS
  Four hundred and five patients met the selection criteria (mean age of 75 years, 54% male), and 67% remained uncorrected at 1 day following the start of FFP administration. Among all patients, 11% died within 30 days of hospital admission. An uncorrected INR was not associated with a higher risk of 30-day mortality for patients overall, but was statistically significant for the subgroup with intracranial hemorrhage (ICH) (adjusted odds ratio 2.55; 95% confidence interval 1.04-6.28).
  
  
  CONCLUSIONS
  Among the subgroup of major bleeding patients with warfarin-associated ICH, those not correcting to either INR ≤ 1.3 or INR ≤ 1.5 with the use of FFP have an increased rate of mortality at 30 days.
authors.affiliation: Outcomes Research, Boston Health Economics, Inc, Waltham, MA 02451, USA. jmenzin@bhei.com
authors.forename: J
authors.initials: J
authors.lastname: Menzin
authors.forename: J
authors.initials: J
authors.lastname: Hoesche
authors.forename: M
authors.initials: M
authors.lastname: Friedman
authors.forename: C
authors.initials: C
authors.lastname: Nichols
authors.forename: G E
authors.initials: GE
authors.lastname: Bergman
authors.forename: M
authors.initials: M
authors.lastname: Crowther
authors.forename: D
authors.initials: D
authors.lastname: Garcia
authors.forename: C
authors.initials: C
authors.lastname: Jones
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects*; D001777:Blood Coagulation / Q000187:drug effects*; D016913:Blood Component Transfusion; D016903:Drug Monitoring / Q000379:methods*; D057286:Electronic Health Records / Q000706:statistics & numerical data*; D005260:Female; D006470:Hemorrhage / Q000097:blood / Q000139:chemically induced* / Q000401:mortality* / Q000628:therapy; D006801:Humans; D019934:International Normalized Ratio; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010949:Plasma; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014859:Warfarin / Q000009:adverse effects*
chemical_list: D000925:Anticoagulants; D014859:Warfarin