title: Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of intravenous infusions of an improved prothrombin complex concentrate (PCC) formulation.
  
  
  METHODS
  Twenty-two adults with haemostatic defects due to severe liver disease (Quick's test 50%), which required rapid haemostasis because of bleeding or before urgent surgery or invasive intervention. Laboratory follow-up, including the response and in-vivo recovery of the substituted coagulation factors II, VII, IX and X and protein C took place before, then 10 min, 30 min and 60 min after PCC substitution. Clinical efficacy (avoidance or cessation of bleeding) was assessed using a scale ranging from 'very good' to 'none'.
  
  
  RESULTS
  Patients received a median PCC dose of 25.7 IU/kg. The response of factor IX and protein C was 1.2-1.4 (IU/dl)/(IU/kg), the in-vivo recovery was 49.7-57.4%, and the Quick's test increased from 39% to a maximum of 65%. Levels of activation markers of the coagulation system factor VIIa, prothrombin fragment 1 + 2 and thrombin antithrombin complex (TAT) increased, but without evidence of any thromboembolic events. Clinical efficacy was judged as 'very good' in 76% of patients after the first (n = 21) treatment. There were no changes in serological status regarding transmission of HIV, hepatitis A virus, hepatitis B virus and hepatitis C virus. No PCC-related adverse reactions occurred.
  
  
  CONCLUSIONS
  The infusion of pasteurized, nanometre-filtered PCC is an effective, well-tolerated method of correcting prothrombin complex deficiency in patients with severe liver disease with haemorrhage, or before an urgent surgical or invasive diagnostic intervention.
authors.affiliation: Klinikum rechts der Isar, II Medizinische Klinik, Technische Universität München, Germany. r.Lorenz@vogtland-klinikum-plauen.de
authors.forename: Reinhard
authors.initials: R
authors.lastname: Lorenz
authors.forename: Joachim
authors.initials: J
authors.lastname: Kienast
authors.forename: Ulrich
authors.initials: U
authors.lastname: Otto
authors.forename: Klaus
authors.initials: K
authors.lastname: Egger
authors.forename: Michael
authors.initials: M
authors.lastname: Kiehl
authors.forename: Dierk
authors.initials: D
authors.lastname: Schreiter
authors.forename: Harald
authors.initials: H
authors.lastname: Kwasny
authors.forename: Sabine
authors.initials: S
authors.lastname: Haertel
authors.forename: Monika
authors.initials: M
authors.lastname: Barthels
mesh_terms: D000328:Adult; D000368:Aged; D001706:Biopsy; D001777:Blood Coagulation; D001779:Blood Coagulation Factors / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D006440:Hemofiltration / Q000379:methods; D006489:Hemostatic Techniques; D006801:Humans; D007262:Infusions, Intravenous; D008107:Liver Diseases / Q000097:blood / Q000150:complications*; D008297:Male; D008875:Middle Aged; D011300:Preoperative Care / Q000379:methods*; D016896:Treatment Outcome; D014766:Viremia / Q000175:diagnosis; D038301:Virus Inactivation
chemical_list: D001779:Blood Coagulation Factors; C025667:prothrombin complex concentrates