Efficacy and Safety of Prothromplex Total (Prothrombin Complex Concentrate) in Oral Anticoagulant Reversal

Inclusion Criteria: * Subject is at least 16 years or older at enrolment with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X), due to oral anticoagulation with vitamin K antagonists (e.g. coumarin, warfarin), requiring reversal of oral anticoagulation for urgent surgery, or invasive procedure or acute bleeding episode * Subject or parent/legally authorised representative has provided written informed consent * Subject has INR \>= 2,0 at screening * Subject is willing and able to comply with the requirements of the protocol Exclusion Criteria: * Subject has laboratory and/or clinical symptoms which are clearly indicative of overt disseminated intravascular coagulation (DIC) * Subject has been treated with whole blood, fresh frozen plasma (FFP), or platelets within 6 hours prior to study enrolment * Subject has a hypersensitivity to prothrombin complex concentrate (PCC) constituents (including heparin-induced thrombocytopenia) * Subject has blood loss of \>= 5 units of blood * Subject has hereditary thrombophilia or bleeding disorder * Subject has a life expectancy of \< 3 months * Subject has been on oral anticoagulant treatment for a period of \< 4 weeks for the treatment of a thrombotic event such as deep vein thrombosis or pulmonary embolism * Subject has an acute ischemic cardiovascular disorder * Subject has or is suspected to have sepsis * Subject with acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C) * Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrolment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study