Ongoing Clinical Trials for Acquired Antithrombin III Deficiency
There is currently 1 ongoing clinical trial for acquired antithrombin III deficiency, also known as heparin resistance. This trial is investigating a plasma-derived treatment for patients undergoing cardiac surgery who do not respond adequately to heparin, a medication used to prevent blood clots during the procedure. The study is being conducted across multiple countries in Europe.
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 clinical trial focuses on patients with heparin resistance, a condition where the body does not respond properly to heparin, a medication used to prevent dangerous blood clots during heart surgery. The condition occurs when there are insufficient levels of antithrombin, a protein that helps regulate blood clotting. This resistance can create significant challenges during cardiac surgery that requires a heart-lung machine, also known as cardiopulmonary bypass.
Who can participate:
- Adults between 18 and 85 years old who are scheduled for heart surgery using cardiopulmonary bypass
- Patients confirmed to have heparin resistance, defined as an activated clotting time (ACT) test result of less than 480 seconds after receiving a standard dose of heparin
- Women of childbearing age must have a negative pregnancy test within 14 days before surgery
- Participants must be able to provide written or electronic informed consent
Who cannot participate:
- Patients who are not adults or not fully developed
- Those who do not have acquired antithrombin deficiency
- Patients not undergoing cardiac surgery with cardiopulmonary bypass
- Those who are not experiencing heparin resistance
What the trial is testing:
The study is investigating a treatment called Atenativ, a medication derived from human plasma that contains antithrombin III. The trial compares Atenativ to a placebo to determine whether it can help patients respond better to heparin during heart surgery. Atenativ works by supplementing the body’s antithrombin levels, which enhances the blood-thinning effect of heparin and helps prevent dangerous blood clots during the procedure.
How the study works:
Participants are randomly assigned to receive either Atenativ or a placebo before their surgery. The study evaluates two different doses of Atenativ to determine the most effective amount for restoring and maintaining heparin responsiveness. During surgery, doctors closely monitor how well the treatment maintains the patient’s response to heparin. After the operation, patients are monitored for 24 hours to assess their recovery, including blood clotting function and any complications such as bleeding.
The study also tracks additional recovery measures, including the length of stay in the intensive care unit, chest tube drainage, and whether any reoperation is needed due to bleeding. Medical professionals carefully monitor participants throughout the entire process to ensure their safety and well-being.
This Phase 3 clinical trial aims to provide important information about whether Atenativ is an effective and safe treatment for patients with heparin resistance undergoing cardiac surgery. The results could help improve outcomes for these patients by ensuring proper blood clot prevention during and after their procedures.
Summary
Currently, there is one clinical trial available for patients with acquired antithrombin III deficiency. The study is being conducted across six European countries: Austria, Czechia, France, Lithuania, Romania, and Slovenia. This wide geographic distribution may provide better access for patients in Central and Eastern Europe who are experiencing heparin resistance during cardiac surgery.
The trial focuses specifically on the use of Atenativ, a human plasma-derived treatment designed to restore the body’s ability to respond to heparin. This represents an important area of research, as heparin resistance can complicate cardiac surgery and increase the risk of blood clots. Patients interested in participating should discuss eligibility with their cardiac surgeon or healthcare provider, particularly if they are scheduled for heart surgery requiring cardiopulmonary bypass.
