Ongoing Clinical Trials for Heparin Resistance
There is currently 1 ongoing clinical trial investigating treatments for heparin resistance, a condition where the body does not respond adequately to heparin during cardiac surgery. This trial is being conducted across multiple European countries and is testing a human plasma-derived treatment called Atenativ to help restore the effectiveness of heparin in patients undergoing heart surgery with cardiopulmonary bypass.
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 Phase 3 clinical trial is investigating a treatment for patients who experience resistance to heparin during cardiac surgery. The condition, known as acquired antithrombin deficiency, occurs when the body has insufficient levels of antithrombin, a protein that helps prevent blood clots. This deficiency makes heparin, a medication used to prevent clotting during surgery, less effective.
Who can participate:
- Adults between 18 and 85 years old
- Patients scheduled for cardiac surgery requiring cardiopulmonary bypass (a heart-lung machine)
- Patients with confirmed heparin resistance, determined by a blood test showing an activated clotting time (ACT) of less than 480 seconds after receiving a standard dose of heparin
- Female patients of childbearing age must have a negative pregnancy test within 14 days before surgery
- Participants must provide informed consent, showing they understand and agree to take part in the study
Who cannot participate:
- Patients under 18 years old
- Patients who do not have acquired antithrombin deficiency
- Patients not undergoing cardiac surgery with cardiopulmonary bypass
- Patients who do not have confirmed heparin resistance
What the trial involves:
The study is testing Atenativ, a medication derived from human plasma that contains Antithrombin III. This treatment aims to restore the body’s response to heparin by supplementing the missing antithrombin protein. Participants will be randomly assigned to receive either Atenativ or a placebo before their surgery.
During the trial, medical professionals will closely monitor how well the treatment maintains the effectiveness of heparin throughout the surgical procedure. The study will evaluate two different doses of Atenativ to determine which is most effective. After surgery, participants will be monitored for 24 hours to assess their recovery and any need for additional treatment.
Main goals:
The primary purpose of this trial is to determine whether Atenativ can effectively restore and maintain heparin responsiveness in patients with resistance during cardiac surgery. Researchers will also evaluate the safety of the treatment and monitor for any side effects. Additional measures include assessing recovery parameters such as chest tube drainage, need for reoperation due to bleeding, length of stay in the intensive care unit, and overall survival outcomes.
The investigational drug being tested, Atenativ, works at the molecular level by supplementing antithrombin, which enhances the anticoagulant effect of heparin. It is classified as an anticoagulant medication and is administered intravenously during the surgical procedure.
Summary
Currently, there is one active clinical trial addressing heparin resistance in patients undergoing cardiac surgery. This Phase 3 study is being conducted across six European countries: Austria, Czechia, France, Lithuania, Romania, and Slovenia. The trial focuses on evaluating Atenativ, a human plasma-derived antithrombin treatment, as a potential solution for patients who do not respond adequately to heparin during heart surgery requiring cardiopulmonary bypass.
The multi-country approach reflects the importance of gathering diverse patient data to better understand the effectiveness and safety of this treatment. Patients interested in participating should consult with their cardiac surgery team to determine if they meet the eligibility criteria and to learn more about what participation would involve.
