title: Evaluation of fixed dose 4-factor prothrombin complex concentrate for emergent warfarin reversal.
abstract: OBJECTIVE
  Four-factor prothrombin complex concentrates (4FPCCs) are emerging as the standard of care for emergent warfarin reversal due to their ability to rapidly and effectively achieve hemostasis. The ideal dose of this medication is not known. Recently, our hospital instituted a protocol where all doses of 4FPCC were a fixed dose of 1500 IU. This protocol provides 4FPCC rapidly and precludes delay waiting for international normalized ratio (INR) values. The purpose of this study was to evaluate our experience with this fixed dose protocol.
  
  
  METHODS
  This is a retrospective review of patients who received 1500 IU of 4FPCC for emergent warfarin reversal between March 2014 and January 2015. Demographic and clinical data regarding administration, efficacy, and safety were collected and analyzed.
  
  
  RESULTS
  A total of 39 patients met inclusion criteria. The most common indication for treatment was intracranial hemorrhage (28, 71.8%). The median INR at presentation was 3.3, and the median INR after a single dose of 1500 IU was 1.4 (P < .001). A total of 36 patients (92.3%) achieved successful reversal with a target INR of less than 2.0, and 28 patients (71.8%) achieved successful reversal with a target INR of 1.5 or less. There were no thrombotic adverse events within 7 days.
  
  
  CONCLUSIONS
  Administration of a fixed dose of 1500 IU of 4FPCC leads to high rates of successful INR reversal and no related thrombotic adverse events within 7 days, and there was no need to wait for INR at presentation. These findings suggest good efficacy and safety when using 1500 IU of 4FPCC for emergent warfarin reversal.
authors.affiliation: Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, USA. Electronic address: lauren.klein@hcmed.org.
authors.forename: Lauren
authors.initials: L
authors.lastname: Klein
authors.affiliation: Transfusion Service, Hennepin County Medical Center, Minneapolis, MN, USA.
authors.forename: Jessica
authors.initials: J
authors.lastname: Peters
authors.affiliation: Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN, USA.
authors.forename: James
authors.initials: J
authors.lastname: Miner
authors.affiliation: Transfusion Service, Hennepin County Medical Center, Minneapolis, MN, USA.
authors.forename: Jed
authors.initials: J
authors.lastname: Gorlin
mesh_terms: D000367:Age Factors; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects*; D001779:Blood Coagulation Factors / Q000008:administration & dosage*; D001835:Body Weight; D002543:Cerebral Hemorrhage / Q000188:drug therapy / Q000517:prevention & control; D002985:Clinical Protocols; D006470:Hemorrhage / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D019934:International Normalized Ratio; D008875:Middle Aged; D012189:Retrospective Studies; D017211:Treatment Failure; D016896:Treatment Outcome; D014859:Warfarin / Q000009:adverse effects*
chemical_list: D000925:Anticoagulants; D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates; D014859:Warfarin