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KCENTRA®

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Product Information	Educational Materials	Conferences and Events	Key Publications

Key Publications

Acquired Bleeding Publications

KCENTRA was approved by the United States (US) food and Drug Administration (FDA) on April 29, 2013. KCENTRA, under the trade name Beriplex or Confidex, has been approved in other countries since 1996. The specific drug product name that was used in the cited publications is referenced below:

Thromboembolism after treatment with 4 factor prothrombin complex concentrate or plasma for warfarin related bleeding

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Go et al. 2022
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INR and vitamin K–dependent factor levels after vitamin K antagonist reversal with 4F-PCC or plasma

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Hood et al. 2022
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Thromboembolic Events After Vitamin K Antagonist Reversal With 4-Factor Prothrombin Complex Concentrate: Exploratory Analyses of Two Randomized, Plasma-Controlled Studies

Milling TJ Jr, et al., Ann Emerg Med 2016
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Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomized trial

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Goldstein JN, et al., Lancet 2015
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Increased risk of volume overload with plasma compared with four-factor prothrombin complex concentrate for urgent vitamin K antagonist reversal

Refaai, MA, et al., Transfusion 2015
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Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: A randomized, plasma-controlled, phase IIIb study

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Sarode R, et al., Circulation 2013
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Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate. A prospective clinical trial of emergency anticoagulation reversal

Pabinger I, et al., Ann Hematol 2010
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Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial

Pabinger I, et al., Thromb Haemost 2008
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Pharmacokinetics of BERIPLEX P/N prothrombin complex concentrate in healthy volunteers

Ostermann H, et al., Thromb Haemost 2007
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Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage

Lorenz R, et al., Eur J Gastroenterol Hepatol 2003
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The referenced CSL Behring product has not been approved by FDA for the use described in these publications, and the safety and effectiveness of the CSL Behring product has not been established for the use described in these publications.

Four-Factor Prothrombin Complex Concentrate (4F-PCC) for the Treatment of Oral Factor Xa Inhibitor-Associated Bleeding: A Meta-Analysis of Fixed Versus Variable Dosing

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