A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure - ANNEXA-RS

Exclusion Criteria

• • The patient requires surgeries or procedures that have a very low chance of causing significant, uncontrollable bleeding, such as small skin procedures, cataract surgery, and minor dental procedures.
• • The patient has acute life-threatening bleeding at the time of Screening.
• • The patient will undergo a surgery or procedure which will require the use of heparin.
• • Patient who is not expected to live for more than three months due to other health problems or has specifically requested not to be resuscitated if their heart stops beating.
• • Prior to screening, the patient had either experienced low platelet count due to heparin use with or without blood clots or had a genetic condition that affects blood clotting.
• • Patient has acute decompensated heart failure, cardiogenic shock, sepsis, or septic shock at the time of Screening.
• • Patient has history of heparin-induced thrombocytopenia (with or without thrombosis) or inherited coagulopathy (eg, anti-thrombin III deficiency, anti-phospholipid antibody syndrome, protein C/S deficiency, Factor V Leiden) at the time of Screening.
• • Previously diagnosed with a bleeding disorder (eg, platelet function disorder, hemophilia, Von Willebrand disease, or coagulation factor deficiency).
• • Prior known hypersensitivity to andexanet alfa.
• • Use of andexanet alfa 30 days prior to Screening.
• • Patient diagnosed with dementia.
• • Any prohibited medication as determined in the study.