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 p…