In short
Currently, there is 1 ongoing clinical trial investigating treatments for acquired antithrombin III deficiency, also known as heparin resistance. This condition affects patients undergoing cardiac surgery who do not respond adequately to heparin, a medication used to prevent blood clots. The trial is being conducted across multiple European countries and is testing a treatment called Atenativ, which is derived from human plasma and contains antithrombin III.
Clinical trial locations
- Austria
- Czechia
- France
- Lithuania
- Romania
- Slovenia
Study on Antithrombin III Human for Patients with Heparin Resistance Undergoing Cardiac Surgery with Cardiopulmonary Bypass
This trial is focused on patients who have developed a condition called heparin resistance, which is a form of acquired antithrombin deficiency. This condition can occur in people scheduled for heart surgery that requires the use of a heart-lung machine, also known as cardiopulmonary bypass.
Main inclusion criteria: Patients eligible for this study must be planning to undergo cardiac surgery with cardiopulmonary bypass and have confirmed heparin resistance, meaning their blood does not respond normally to heparin. This is determined by a specific blood clotting test called the Hemochron ACT test, which should show a result of less than 480 seconds after receiving a standard dose of heparin. Participants must be between 18 and 85 years old and must provide informed consent to participate. Female participants of childbearing age must have a negative pregnancy test within 14 days before surgery.
Main exclusion criteria: The study excludes patients who are not adults, those who do not have acquired antithrombin deficiency, those not undergoing cardiac surgery with cardiopulmonary bypass, and those who are not experiencing heparin resistance.
Focus and goal: The primary goal of this trial is to evaluate whether Atenativ, a treatment derived from human plasma containing antithrombin III, can help restore and maintain the effectiveness of heparin in patients who are resistant to it. During the study, participants will be randomly assigned to receive either Atenativ or a placebo before surgery. The medical team will carefully monitor how well the treatment works in maintaining heparin responsiveness throughout the surgical procedure. The trial also assesses the safety of Atenativ and tracks any side effects that may occur. Participants will undergo several follow-up visits after surgery, during which their recovery, including blood clotting function and any complications, will be evaluated. The study examines factors such as the length of stay in the intensive care unit and overall recovery parameters.
Investigational drug: Atenativ is a medication made from human plasma that contains antithrombin III, a protein that helps regulate blood clotting. It is administered intravenously and works by supplementing the body's natural antithrombin levels, thereby enhancing the blood-thinning effect of heparin. This treatment is currently being studied in a Phase 3 clinical trial to determine its effectiveness and safety in patients with heparin resistance during cardiac surgery.
Summary
Currently, there is only one ongoing clinical trial for acquired antithrombin III deficiency, reflecting the specialized nature of this condition. The trial is being conducted across six European countries: Austria, Czechia, France, Lithuania, Romania, and Slovenia, indicating a collaborative European effort to study this condition. The trial focuses specifically on patients undergoing cardiac surgery with cardiopulmonary bypass who experience heparin resistance, a particular manifestation of acquired antithrombin deficiency. The investigational treatment being studied is Atenativ, a human plasma-derived product containing antithrombin III. This Phase 3 trial aims to determine whether supplementing antithrombin can effectively restore heparin responsiveness in affected patients, which could improve surgical outcomes and safety during complex cardiac procedures.
