title: Argatroban in the management of heparin-induced thrombocytopenia: a multicenter clinical trial.
abstract: BACKGROUND
  The aim of this study was to collect data in France in patients with heparin-induced thrombocytopenia who required parenteral anticoagulation and for whom other non-heparin anticoagulant therapies were contraindicated including patients with renal failure, cross-reactivity to danaparoid or at high hemorrhagic risk.
  
  
  METHODS
  A total of 20 patients, of mean age 72 ± 10 years, were enrolled in this open-label, multicenter clinical study. Exploratory statistical data analysis was performed with descriptive interpretation of intra-individual comparisons using simple univariate statistics.
  
  
  RESULTS
  The diagnosis of HIT was confirmed in 16 subjects by an independent scientific committee. Fourteen patients (70 %) were in an intensive care unit during the course of the study. Patients were treated with argatroban for a mean duration of 8.5 ± 6.1 days. The mean starting dose of argatroban was 0.77 ± 0.45 μg/kg/min. Platelet recovery was rapid. aPTT and anti-IIa activity assays were used to monitor the dose of argatroban. The mean baseline aPTT value was 45.0 ± 9.8 sec and increased to 78.2 ± 35.8 sec two hours after initiating argatroban. At this time mean argatroban concentration was 0.34 ± 0.16 and 0.61 ± 0.28 μg/ml using ECT and TT measurements, respectively. New and/or extended thromboses were reported in 25 % of patients and major bleedings were documented in 15 %. Six patients died due to their underlying medical condition.
  
  
  CONCLUSIONS
  Considering its hepatic elimination and its short half-life, argatroban can be considered as a safe therapeutic option in HIT patients at high hemorrhagic risk and with renal failure, particularly in an ICU setting.
authors.affiliation: EA 3065, Université Jean-Monnet, INSERM CIC 1408 - FCRIN-INNOVTE - Laboratory of Hematology, University Hospital of St Etienne, St Etienne, France. brigitte.tardy@chu-st-etienne.fr.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Tardy-Poncet
authors.affiliation: Laboratory of Hematology, University Hospital of Reims, Reims, France. pnguyen@chu-reims.fr.
authors.forename: Philippe
authors.initials: P
authors.lastname: Nguyen
authors.affiliation: Department of Cardiovascular Surgery, University Hospitals of Strasbourg, Strasbourg, France. thiranos.jean-claude@wanadoo.fr.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Thiranos
authors.affiliation: Laboratory of Hematology, University Hospital of Marseille, Marseille, France. pierre.morange@ap-hm.fr.
authors.forename: Pierre-Emmanuel
authors.initials: PE
authors.lastname: Morange
authors.affiliation: Laboratory of Hematology, University Hospital of Montpellier, Montpellier, France. c-biron@chu-montpellier.fr.
authors.forename: Christine
authors.initials: C
authors.lastname: Biron-Andréani
authors.affiliation: Laboratory of Hematology, University Hospital of Tours, Tours, France. gruel@med.univ-tours.fr.
authors.forename: Yves
authors.initials: Y
authors.lastname: Gruel
authors.affiliation: Department of Intensive Care Unit, University Hospital of St Etienne, St Etienne, France. jerome.morel@chu-st-etienne.fr.
authors.forename: Jérome
authors.initials: J
authors.lastname: Morel
authors.affiliation: University Hospital of Reims, Reims, France. awynckel@chu-reims.fr.
authors.forename: Alain
authors.initials: A
authors.lastname: Wynckel
authors.affiliation: Laboratory of Hematology, University Hospitals of Strasbourg, Strasbourg, France. Lelia.Grunebaum@chru-strasbourg.fr.
authors.forename: Lelia
authors.initials: L
authors.lastname: Grunebaum
authors.affiliation: Intensive Care Unit, University Hospital of Marseille, Marseille, France. Judith.VILLACORTATORRES@ap-hm.fr.
authors.forename: Judith
authors.initials: J
authors.lastname: Villacorta-Torres
authors.affiliation: Intensive Care Medicine, University Hospital of Dijon, Dijon, France. sandrine.grosjean@chu-dijon.fr.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Grosjean
authors.affiliation: Laboratory of Hematology, University Hospital of Dijon, Dijon, France. emmanuel.demaistre@chu-dijon.fr.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: de Maistre
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D001120:Arginine / Q000031:analogs & derivatives; D005260:Female; D006493:Heparin / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010314:Partial Thromboplastin Time; D010875:Pipecolic Acids / Q000627:therapeutic use*; D010976:Platelet Count; D013449:Sulfonamides; D013921:Thrombocytopenia / Q000139:chemically induced / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D010875:Pipecolic Acids; D013449:Sulfonamides; D006493:Heparin; D001120:Arginine; C031942:argatroban