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.