title: Clinical effectiveness and safety outcomes associated with prothrombin complex concentrates.
abstract: Prothrombin complex concentrates (PCCs) are indicated for urgent reversal of warfarin and used for reversal of novel oral anticoagulants, in patients with acute major bleeding or need for an urgent procedure. The research goal was to evaluate effectiveness and safety outcomes with PCC usage at our institution. A retrospective review of electronic medical records identified patients that received a PCC commercially available in the United States (KCentra(®) or Profilnine(®)) at twelve hospitals in a tertiary care health system from July 1, 2013 to April 30, 2014. A total of 193 patients received PCC, of which 184 patients received four-factor PCC. The patient population was 48 % male and 75 % Caucasian, with a mean age of 73 years old. Clinical outcomes of interest included time to achieve a target INR ≤1.3, time to Hgb >7 g/dL, and incidence of thromboembolism. A total of 143 patients were on warfarin (74.1 %) at baseline, whereas 18 patients (9.3 %) were taking a novel anticoagulant. Target INR of ≤1.3 was achieved in 125 patients (65.8 %), within a median time of 8.03 h (IQR 3.38-34.07). Among patients with a baseline Hgb <7 g/L (n = 13), the median time to Hgb >7 g/dL was 8.48 h (IQR 6.95-13.00). Eight patients (4.1 %) developed an acute venous thromboembolism following PCC administration. INR reversal was achieved in approximately two-thirds of patients, with a low incidence of venous thromboembolism. Four-factor PCC is a viable alternative to plasma.
authors.affiliation: Department of Pharmacy Services, University of Utah Hospital and Clinics, 50 N Medical Drive, Salt Lake City, UT, 84132, USA.
authors.forename: Ashley
authors.initials: A
authors.lastname: Hedges
authors.affiliation: University of Pittsburgh School of Pharmacy, 727 Salk Hall, 3501 Terrace Street, Pittsburgh, PA, 15261, USA. coonsjc@upmc.edu.
authors.forename: James C
authors.initials: JC
authors.lastname: Coons
authors.affiliation: Department of Medicine, University of Pittsburgh, 1216 Kaufman Building, Pittsburgh, PA, 15213, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Saul
authors.affiliation: Hematology/Oncology Division, UPMC Presbyterian-Shadyside Hospital, 5150 Centre Avenue, Pittsburgh, PA, 15232, USA.
authors.forename: Roy E
authors.initials: RE
authors.lastname: Smith
mesh_terms: D000368:Aged; D001779:Blood Coagulation Factors / Q000008:administration & dosage / Q000494:pharmacology*; D004347:Drug Interactions; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006470:Hemorrhage / Q000188:drug therapy; D006801:Humans; D019934:International Normalized Ratio; D008297:Male; D061214:Patient Safety; D010599:Pharmacokinetics; D012189:Retrospective Studies; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000139:chemically induced
chemical_list: D001779:Blood Coagulation Factors; D006454:Hemoglobins; C025667:prothrombin complex concentrates
keywords: Hemorrhage; Hemostasis; Prothrombin complex concentrates; Warfarin