title: Treatment of warfarin-related intracranial hemorrhage: a comparison of prothrombin complex concentrate and recombinant activated factor VII.
abstract: OBJECTIVE
  Warfarin-related intracranial hemorrhage (ICH) is a devastating complication of warfarin therapy. Several studies have demonstrated successful correction of the international normalized ratio (INR) using prothrombin complex concentrate (PCC) or recombinant activated factor VII (rFVIIa). To our knowledge, no study has directly compared these agents for treatment of warfarin-related ICH.
  
  
  METHODS
  We retrospectively reviewed the charts of 15 patients who received rFVIIa and 9 who received PCC for treatment of warfarin-related ICH over a 2-year period. The primary objective was to compare the efficacy of rFVIIa and PCC in correcting the INR to 1.3 or less. Baseline INR was compared to INR obtained within 1, 3, 6, 12, and 24 hours after rFVIIa or PCC administration.
  
  
  RESULTS
  Six patients in the rFVIIa group and five in the PCC group had a follow-up INR within 1 hour of agent administration. In the rFVIIa group, the mean INR decreased from 6.1 to 1.1 and from 2.3 to 1.48 in the PCC group. At 6 hours, all rFVIIa patients and six (67%) PCC patients had at least one subsequent INR, with 93% and 50% correcting to an INR of 1.3 or less. Mean dose for all patients included was 53.4 ± 17.5 μg/kg and 27.8 ± 15.4 units/kg for rFVIIa and PCC, respectively.
  
  
  CONCLUSIONS
  Correction of the INR is more reliably obtained with rFVIIa when compared to PCC. Larger, prospective studies comparing these therapies for warfarin-related ICH are needed.
authors.affiliation: Department of Pharmacy Practice, Auburn University, Tuscaloosa, Alabama, USA. nap0003@auburn.edu
authors.forename: Nathan A
authors.initials: NA
authors.lastname: Pinner
authors.forename: April C
authors.initials: AC
authors.lastname: Hurdle
authors.forename: Carrie
authors.initials: C
authors.lastname: Oliphant
authors.forename: Anne
authors.initials: A
authors.lastname: Reaves
authors.forename: Bob
authors.initials: B
authors.lastname: Lobo
authors.forename: Allen
authors.initials: A
authors.lastname: Sills
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects*; D001777:Blood Coagulation / Q000187:drug effects; D001779:Blood Coagulation Factors / Q000008:administration & dosage*; D015942:Factor VIIa / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D019934:International Normalized Ratio; D020300:Intracranial Hemorrhages / Q000139:chemically induced / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000008:administration & dosage; D012189:Retrospective Studies; D016896:Treatment Outcome; D014859:Warfarin / Q000009:adverse effects*
chemical_list: D000925:Anticoagulants; D001779:Blood Coagulation Factors; D011994:Recombinant Proteins; C025667:prothrombin complex concentrates; D014859:Warfarin; D015942:Factor VIIa