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

Launched by OCTAPHARMA · Oct 17, 2023

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ClinConnect Summary

This clinical trial is studying a treatment called Atenativ, which is derived from human plasma, to see if it can help patients who are resistant to heparin during cardiac surgery. Heparin is a medication used to prevent blood clots, and some patients have difficulty responding to it. The trial aims to find out if two different doses of Atenativ can restore and maintain the effectiveness of heparin in adult patients scheduled for surgery that requires a heart-lung machine (called cardiopulmonary bypass).

To be eligible for this trial, participants must be between 18 and 85 years old and have a planned cardiac surgery involving cardiopulmonary bypass. They must also be experiencing heparin resistance, which means their blood does not respond well to heparin. Participants can expect to receive either Atenativ or a placebo (a treatment with no active medication) during the study, and all will be closely monitored for safety and effectiveness. If you have any concerns, such as a history of bleeding problems or certain allergies, it’s important to discuss these with your doctor, as they may affect your eligibility for the trial.

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Eligibility criteria

• Inclusion 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
• 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, 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