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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
EU CTIS ID: 2023-507560-39-00
What this study is testing
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Planned cardiac surgery with CPB
- Heparin-resistant patients: pre-CPB Hemochron ACT less than 480 seconds in the measurement performed between 2 and 5 minutes following intravenous administration of 500 U/kg BW UFH
- Patients ≥18 and ≤85 years of age
- Freely given written or electronic informed consent
- In female patients of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile), a pre-existing negative pregnancy test within 14 days prior to surgery
You likely can't join if
- Receiving or have received one or more of the following medications within the specified time frames prior to the start of the surgery: a) vitamin K antagonists (within 3 days) b) direct oral anticoagulants (within 2 days) c) thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory d) ticagrelor (within 5 days), unless platelet function is satisfactory e) glycoprotein IIb/IIIa antagonist (within 24 hours)
- Pre-existing coagulopathy, a history of bleeding problems or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)
- Renal insufficiency, defined as serum creatinine level >2.0 mg/dL
- Thrombocytosis, defined as platelet count >400,000 per µL
- Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ, i.e., human albumin, sodium chloride, acetyl tryptophan and caprylic acid
- History of anaphylactic reaction(s) to blood or blood components
See the full eligibility criteria
- Planned cardiac surgery with CPB
- Heparin-resistant patients: pre-CPB Hemochron ACT less than 480 seconds in the measurement performed between 2 and 5 minutes following intravenous administration of 500 U/kg BW UFH
- Patients ≥18 and ≤85 years of age
- Freely given written or electronic informed consent
- In female patients of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile), a pre-existing negative pregnancy test within 14 days prior to surgery
- Receiving or have received one or more of the following medications within the specified time frames prior to the start of the surgery: a) vitamin K antagonists (within 3 days) b) direct oral anticoagulants (within 2 days) c) thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory d) ticagrelor (within 5 days), unless platelet function is satisfactory e) glycoprotein IIb/IIIa antagonist (within 24 hours)
- Pre-existing coagulopathy, a history of bleeding problems or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)
- Renal insufficiency, defined as serum creatinine level >2.0 mg/dL
- Thrombocytosis, defined as platelet count >400,000 per µL
- Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ, i.e., human albumin, sodium chloride, acetyl tryptophan and caprylic acid
- History of anaphylactic reaction(s) to blood or blood components
- Refusal to receive transfusion of blood or blood-derived products
- Current participation in another interventional clinical trial with an investigational medicinal product (IMP) or previous participation in the current trial
- Treatment with any IMP within 30 days prior to screening visit
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Canada
- Serbia
- Turkey
- Kazakhstan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Canada; Serbia; Turkey; Kazakhstan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.