Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass

Exclusion Criteria

• •1. Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:
• •1. vitamin K antagonists (within 3 days)
• •2. direct oral anticoagulants (within 2 days)
• •3. thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory according to local standard of care assessment
• •4. ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment
• •5. glycoprotein IIb/IIIa antagonist (within 24 hours)
• •2. Pre-existing coagulopathy, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)
• •3. Renal insufficiency, defined as serum creatinine level \>2.0 mg/dL
• •4. Thrombocytosis, defined as platelet count \>400,000 per μL
• •5. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ, i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid
• •6. History of anaphylactic reaction(s) to blood or blood components
• •7. Refusal to receive transfusion of blood or blood-derived products
• •8. Current participation in another interventional clinical trial or previous participation in the current trial
• •9. Treatment with any IMP within 30 days prior to screening visit