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

Eligibility Criteria

• 1. Planned cardiac surgery with CPB
• 2. Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U/kg UFH)
• 3. Patients between 18 and 85 years of age, inclusive
• 4. Freely given written or electronic informed consent
• 5. In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery
• 1. Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:
• 1. warfarin (within 3 days)
• 2. direct oral anticoagulants (within 2 days)
• 3. ticlopidine (within 14 days)
• 4. prasugrel (within 7 days)
• 5. clopidogrel (within 5 days)
• 6. ticagrelor (within 5 days)
• 7. glycoprotein IIb/IIIa antagonist (within 1 day)
• 2. Pre-existing coagulopathy, a history of bleeding problems, 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 \>1.5 mg/dL
• 4. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid
• 5. History of anaphylactic reaction(s) to blood or blood components
• 6. Refusal to receive transfusion of blood or blood-derived products
• 7. Current participation in another interventional clinical trial or previous participation in the current trial
• 8. Treatment with any IMP within 30 days prior to screening visit