Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.

The primary objective of the study is to demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitami n K Antagonist (VKA)therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex® P/N (Kcentra).

The secondary objective of the study is to investigate the safety and tolerability of OCTAPLEX compared to Beriplex® P/N (Kcentra) in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk.

Inclusion criteria

• Male or female patients at least 18 years of age.
• Patients currently on oral anticoagulation treatment with VKA of coumadin or warfarin type.
• Patients being admitted to the hospital or currently hospitalized where:

• an urgent surgery carrying significant bleeding risk (≥50 mL expected blood loss) is required as part of routine clinical care;
• the use of oral or parenteral vitamin K alone to reverse anticoagulation is deemed too slow or inappropriate for reversal;
• Patients with an international normalized ratio (INR) of 2.0 or above at the time of decision to reverse the anticoagulation status.
• Patients who have given written informed consent and who are able and willing to comply with the procedures described in the study protocol.

Exclusion criteria

• Patients with a life expectancy of less than 48 hours per physician's judgment (e.g. patients with a Glasgow Coma Scale equal to 3 or a Head Abbreviated Injury Score of 6, patients requiring continuous inotropic or pressor support, and patients whose status is post cardiac arrest).
• Patients for whom the planned surgery or procedure is commonly associated with a very low bleeding risk (e.g. catheter placement, gastroscopy).
• Patients with a history of thromboembolic events (TEEs), myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebrovascular accident, transient ischemic attack, severe peripheral vascular disease, or disseminated intravascular coagulation within 3 months of enrollment.
• Patients with a known congenital bleeding disorder.
• Patients with a known antiphospholipid antibody syndrome.
• Patients with present or past specific factor inhibitor activity.
• Patients with thrombocytopenia of <80,000/μL or history of heparin-induced thrombocytopenia.
• Patients who have received heparin of any type or any non-VKA anticoagulant within 24 hours prior to enrollment into the study or with potential need to receive these medications before completion of hemostasis evaluation at the end of surgery.
• Patients who have received prothrombin complex concentrates (PCCs), fresh frozen plasma or vitamin K within 72 hours prior to enrollment into the study.
• Patients with a known history of hypersensitivity to plasma-derived products.
• Patients with acute major bleeding or polytrauma.
• Pregnant or nursing women.
• Patients participating in another interventional clinical study currently or during the past 30 days prior to enrollment into this study.
• Patients previously enrolled in this study.