An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure

Inclusion Criteria: * Male and female subjects greater than or equal to 18 years, * Subjects currently on oral vitamin K antagonist (VKA) therapy, * An urgent surgical procedure is required within 24 hours of the start of investigational medicinal product (IMP), * Due to the nature of the procedure, withdrawal of oral VKA therapy and infusion of plasma are also indicated to reverse the VKA effect, * INR greater than or equal to 2 within 3 hours before start of IMP, * Informed consent has been obtained. Exclusion Criteria: * Subjects requiring urgent surgical procedures where according to the surgeon's clinical judgment, an accurate estimate of blood loss is not possible (e.g., ruptured aneurysm), * Subjects for whom administration of intravenous vitamin K and vitamin K antagonists withdrawal alone can adequately correct the subject's coagulopathy before initiation of the urgent surgical procedure, * Administration of intravenous vitamin K more than 3 hours or administration of oral vitamin K more than 6 hours prior to infusion of IMP, * Subjects in whom lowering INR within normal range may present an unacceptable risk for a thromboembolic complication where the INR goal is to lower but not normalize the INR because of risk of a procedure-associated stroke, * Subjects, who despite medical management that includes close monitoring and diuretics, may not, by investigator assessment, tolerate the total volume of IMP required by the protocol, * Expected need for additional non-study blood products before infusion of IMP (Note: Administration of packed red blood cells is not an exclusion criterion), * Expected need for platelet transfusions or desmopressin before Day 10, * Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control or resolve an acute bleeding complication and/or control the acute bleeding event, * Unfractionated or low molecular weight heparin use within 24 hours before randomization or potential need before completion of the procedure, * History of thromboembolic event, myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebral vascular accident, transient ischemic attack, severe peripheral vascular disease, disseminated intravascular coagulation within 3 months of enrollment, * Reversal of VKA therapy alone may not resolve the coagulopathy (eg, receiving a potent anti-platelet agent, i.e., clopidogrel or prasugrel, or advanced liver disease), * Known history of antiphospholipid antibody syndrome or lupus anticoagulant antibodies, * Suspected or confirmed serious viral or bacterial infection, e.g., meningitis, or sepsis at time of enrollment, * Administration of whole blood, plasma, plasma fractions or platelets within 2 weeks prior to inclusion into the study (Note: Administration of packed red blood cells is not an exclusion criterion), * Pre-existing progressive fatal disease with a life expectancy of less than 2 months, * Known inhibitors to coagulation factors II, VII, IX, or X; or hereditary protein C or protein S deficiency; or heparin-induced, type II thrombocytopenia, * Treatment with any other investigational medicinal product within 30 days prior to inclusion into the study, * Presence or history of hypersensitivity to components of the study medication, * Pregnant or breast-feeding women, * Prior inclusion in this study or any other CSL Behring sponsored Beriplex study, * For subjects with intracranial hemorrhage with: * Glasgow Coma Score \<10 (see Appendix 8) * Modified Rankin Score \> 3 prior to ICH (see Appendix 9) * Intracerebral hemorrhage * Epidural hematomas * Infratentorial hemorrhage * Subarachnoid hemorrhage (SAH) subjects with a Hunt and Hess Scale \>2 * Subdural hematomas that: * are judged to be an acute subdural hematoma (based on neurosurgeon review) * have a concurrent SAH or parenchymal contusion