Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures

Inclusion Criteria: * Male or female patients at least 18 years of age. * Patients receiving oral anticoagulation with coumadin or warfarin derived agents. * Patients who have need for urgent surgery or an invasive procedure up to 8 hours after admission or identification of a patient currently hospitalized, where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of coumadin or warfarin anticoagulant effects. * Patients with an international normalized ratio (INR) of 2.0 or above. * Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legal representative on their behalf. * Patients able and willing to comply with the procedures laid out in the study protocol. In the case of unconscious and/or incapacitated patients, the willingness of the patient's legal representative for the patient to undergo the procedures laid out in the study protocol. Exclusion Criteria: * Patients with a life expectancy of less than 48 hours (eg, patients with a Glasgow Coma Scale (GCS) equal to 3 or a head abbreviated injury score (AIS) of 6, patients requiring continuous inotropic or pressor support, patients status post-cardiac arrest). * Patients with a history within the last 6 months of disseminated intravascular coagulation (DIC), or hyperfibrinolysis. * Patients with a known congenital coagulation disorder. * Patients with known antiphospholipid antibody syndrome or have known lupus anticoagulant antibodies. * Patients with present or past specific factor inhibitor activity. * Patients with thrombocytopenia of \< 80,000 or a history of heparin induced thrombocytopenia (HIT). * Patients having received heparin of any type or any non-coumadin or warfarin anticoagulant immediately prior and/or intended to be given within the first 1 hour post-infusion. * Patients who have received vitamin K more than 3 hours prior to the infusion of study drug. * Patients with a history of hypersensitivity to plasma-derived products. * Pregnant or nursing women. * Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion. * Patients previously enrolled in this study.