title: Use of recombinant factor VIIa in patients with warfarin-associated intracranial hemorrhage.
abstract: BACKGROUND
  Warfarin-associated intracranial hemorrhage (ICH) requires rapid normalization of clotting function. Current therapies are associated with significant complications and/or prolonged time to correction of coagulopathy. Recombinant factor VIIa (FVIIa) might allow faster and safer correction of coagulopathy.
  
  
  METHODS
  This article presents a retrospective chart review of all patients with warfarin-associated ICH treated in a neurology/neurosurgery intensive care unit over an 11-month period.
  
  
  RESULTS
  All patients were treated to rapidly reverse the warfarin effect. Fifteen patients received vitamin K and fresh frozen plasma (FFP) alone (FFP group). Twelve patients also received FVIIa (FVIIa group). The median times from presentation to an international normalization ratio (INR) of less than 1.3 were 32.2 and 8.8 hours in the FFP the FVIIa groups, respectively (p = 0.016). INR normalized slowly (at 110 and 130 hours, respectively) in two patients with end-stage renal failure who were given FVIIa, one of whom developed disseminated intravascular coagulation after three doses of FVIIa. No other complications occurred from FVIIa administration. One patient in the FFP group developed severe pulmonary edema.
  
  
  CONCLUSIONS
  FVIIa may be an effective adjunct to FFP in warfarin-related ICH, facilitating faster correction of INR and decreasing FFP requirements. A prospective, randomized trial is needed to confirm these preliminary findings and to determine whether there is a clinical benefit.
authors.affiliation: Neurology/Neurosurgery Intensive Care Unit, Department of Neurology, Washington University School of Medicine, St. Louis, MO 63110, USA.
authors.forename: David L
authors.initials: DL
authors.lastname: Brody
authors.forename: Venkatesh
authors.initials: V
authors.lastname: Aiyagari
authors.forename: Angela M
authors.initials: AM
authors.lastname: Shackleford
authors.forename: Michael N
authors.initials: MN
authors.lastname: Diringer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects*; D000933:Antifibrinolytic Agents / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005167:Factor VII / Q000008:administration & dosage / Q000627:therapeutic use*; D015942:Factor VIIa; D005260:Female; D006801:Humans; D019934:International Normalized Ratio; D020300:Intracranial Hemorrhages / Q000139:chemically induced* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010949:Plasma; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D012189:Retrospective Studies; D016896:Treatment Outcome; D014812:Vitamin K / Q000627:therapeutic use; D014859:Warfarin / Q000009:adverse effects*
chemical_list: D000925:Anticoagulants; D000933:Antifibrinolytic Agents; D011994:Recombinant Proteins; D014812:Vitamin K; D014859:Warfarin; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa