Patients of both studies were randomly assigned (1: 1) to receive either 4F-PCC (Kcentra
, Beriplex P/N, CSL Behring, Marburg, Germany) or plasma.
PCC complexes have been administered as either three- or four-factor agents, with the four-factor PCC (KCentra) becoming widely used at this time.
Before 2015, reversal of dabigatran was limited to the use of FFP, rVIIa, and PCC (marketed in the United States as KCentra [CSL Behring]).
Anonactivated, 4-factor prothrombin complex concentrate (4F-PCC) known as Kcentra (CSL Behring, Kankakee, Illinois) has been approved in the United States for the reversal of vitamin K antagonist (VKA) anticoagulation in patients with major acute hemorrhage, or in patients who require urgent surgical intervention.
For instance, the analogue to Kcentra is Beriplex (CSL Behring, Marburg, Germany), a product widely used in Europe.
Kcentra contains factors II, VII, IX, and X in addition to the natural anticoagulants protein C and protein S (1) (see Table 2 for additional details on the contents of 4F-PCCs and FFP).
Kcentra has been approved in the United States for the reversal of VKA anticoagulation in patients with major acute hemorrhage, or in patients who require urgent surgical intervention.
 US Food and Drug Administration, "FDA approves Kcentra
for the urgent reversal of anticoagulation in adults with major bleeding," 2013.
(6,13) Agents that may be used to reverse the effects of dabigatran such as the activated prothrombin complex concentrate (FEIBA; Baxter, Deerfield, Illinois) and the recently approved 4-component prothrombin complex concentrate (Kcentra
; CSL Behring, King of Prussia, Pennsylvania) may be effective, but without laboratory guidance the dosing is difficult, and thrombosis may result.