prothrombin complex concentrate (Autoplex-T, Kcentra)

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Introduction

Contains vitamin K-dependent clotting factors:

Prepared from pooled human plasma.

Variable in content.

* 4 factor prothrombin complex concentrate can restore clotting activity in ~100% of patients

* 3 factor prothrombin complex concentrate lacks factor VII & requires supplemental fresh frozen plasma or recombinant factor VIIa[4]

Indications

Contraindications

Dosage

* small volume; stored at room temp; no need for ABO typing

More general terms

Components

References

  1. Hagstrom SJ and Harper JL eMedicine: Hypoprothrombinemia http://emedicine.medscape.com/article/956030-overview
  2. 2.0 2.1 2.2 Eerenberg ES et al. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: A randomized, placebo-controlled, crossover study in healthy subjects. Circulation 2011 Oct 4; 124:1573. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21900088
    Battinelli EM. Reversal of new oral anticoagulants. Circulation 2011 Oct 4; 124:1508. PMID: https://www.ncbi.nlm.nih.gov/pubmed/21969317
  3. 3.0 3.1 FDA News Release: April 29, 2013 FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350026.htm
    Prescriber's Letter 20(10): 2013 ALGORITHM: How to Manage High INRs in Warfarin Patients CHART: Clotting Factors for Reversing Anticoagulants Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=291012&pb=PRL (subscription needed) http://www.prescribersletter.com
  4. 4.0 4.1 4.2 4.3 4.4 Medical Knowledge Self Assessment Program (MKSAP) 17, 18, 19. American College of Physicians, Philadelphia 2015, 2018, 2022.
  5. 5.0 5.1 Sarode R, Milling TJ Jr, Refaai MA et al 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. Circulation. 2013 Sep 10;128(11):1234-43 PMID: https://www.ncbi.nlm.nih.gov/pubmed/23935011
  6. Goldstein JN, Refaai MA, Milling TJ Jr, et al 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, randomised trial. Lancet. 2015 May 23;385(9982):2077-87. Epub 2015 Feb 27. PMID: https://www.ncbi.nlm.nih.gov/pubmed/25728933