Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage

Eur J Gastroenterol Hepatol. 2003 Jan;15(1):15-20. doi: 10.1097/00042737-200301000-00004.


Objective: To evaluate the efficacy and safety of intravenous infusions of an improved prothrombin complex concentrate (PCC) formulation.

Patients and 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.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Biopsy
  • Blood Coagulation
  • Blood Coagulation Factors / adverse effects
  • Blood Coagulation Factors / metabolism
  • Blood Coagulation Factors / therapeutic use*
  • Drug Administration Schedule
  • Female
  • Gastrointestinal Hemorrhage / drug therapy*
  • Gastrointestinal Hemorrhage / etiology
  • Hemofiltration / methods
  • Hemostatic Techniques*
  • Humans
  • Infusions, Intravenous
  • Liver Diseases / blood
  • Liver Diseases / complications*
  • Male
  • Middle Aged
  • Preoperative Care / methods*
  • Treatment Outcome
  • Viremia / diagnosis
  • Virus Inactivation


  • Blood Coagulation Factors
  • prothrombin complex concentrates