• J. Thromb. Haemost. · Apr 2008

    Multicenter Study Clinical Trial

    Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial.

    • I Pabinger, B Brenner, U Kalina, S Knaub, A Nagy, H Ostermann, and Beriplex P/N Anticoagulation Reversal Study Group.
    • Department of Internal Medicine, Division of Haematology and Haemostaseology, Medical University Vienna, Vienna, Austria.
    • J. Thromb. Haemost. 2008 Apr 1;6(4):622-31.

    BackgroundProthrombin complex concentrate (PCC) can substantially shorten the time needed to reverse antivitamin K oral anticoagulant therapy (OAT). OBJECTIVES. To determine the effectiveness and safety of emergency OAT reversal by a balanced pasteurized nanofiltered PCC (Beriplex P/N) containing coagulation factors II, VII, IX, and X, and anticoagulant proteins C and S.Patients And MethodsPatients receiving OAT were eligible for this prospective multinational study if their International Normalized Ratio (INR) exceeded 2 and they required either an emergency surgical or urgent invasive diagnostic intervention or INR normalization due to acute bleeding. Stratified 25, 35, or 50 IU kg(-1) PCC doses were infused based on initial INR. Study endpoints included INR normalization (ResultsForty-three patients, 26 requiring interventional procedures and 17 experiencing acute bleeding, received PCC infusions at a median rate of 7.5 mL min(-1) (188 IU min(-1)). At 30 min thereafter, INR declined to ConclusionsPCC treatment serves as an effective rapid hemorrhage control resource in the emergency anticoagulant reversal setting. More widespread availability of PCC is warranted to ensure its benefits in appropriate patients.

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