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
- prothrombin deficiency
- reversal of vitamin K antagonist (warfarin) anticoagulation in adults with major bleeding[3][4][5] (treatment of choice)[4]
- reversal of rivaroxaban anticoagulation[2]
Contraindications
- does not reverse dabigatran anticoagulation[2]
- coagulopathy of liver disease[4]
Dosage
- start with 25-50 U/kg of factor IX content or factor VIII correctional unit equivalent, IV infusion
- QD or QOD dosing
* small volume; stored at room temp; no need for ABO typing
More general terms
Component of
Components
- coagulation factor IX; Christmas factor; plasma thromboplastin component; PTC; contains: coagulation factor IXa light chain; coagulation factor IXa heavy chain (F9)
- coagulation factor VII; proconvertin; serum prothrombin conversion accelerator; SPCA; Eptacog alfa; contains: factor VII light chain; factor VII heavy chain (F7)
- coagulation factor X; Stuart factor; Stuart-Prower factor; contains: factor X light chain; factor X heavy chain; activated factor Xa heavy chain (F10)
- protein C; vitamin K-dependent protein C; anticoagulant protein C; autoprothrombin IIA; blood coagulation factor XIV; contains: vitamin K-dependent protein C light chain; vitamin K-dependent protein C heavy chain; activation peptide (PROC)
- protein S; vitamin K-dependent protein S (PROS1, PROS)
- prothrombin; coagulation factor II; contains: activation peptide fragment 1; activation peptide fragment 2; thrombin light chain; thrombin heavy chain (F2)
References
- ↑ Hagstrom SJ and Harper JL eMedicine: Hypoprothrombinemia http://emedicine.medscape.com/article/956030-overview
- ↑ Jump up to: 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 - ↑ Jump up to: 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 - ↑ Jump up to: 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.
- ↑ Jump up to: 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
- ↑ 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