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Study on Antithrombin III Human for Patients with Heparin Resistance Undergoing Cardiac Surgery with Cardiopulmonary Bypass

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who have a condition known as Heparin Resistance, which is a type of Acquired Antithrombin Deficiency. This condition can occur in patients who are scheduled to undergo heart surgery that requires the use of a heart-lung machine, also known as cardiopulmonary bypass. The study is testing a treatment called Atenativ, which is derived from human plasma and contains a substance called Antithrombin III. This treatment is being compared to a placebo to see if it can help patients respond better to heparin, a medication used to prevent blood clots during surgery.

The purpose of the study is to evaluate how effective Atenativ is in helping patients who do not respond well to heparin. Participants in the study will receive either Atenativ or a placebo before their surgery. The study will monitor how well the treatment works in maintaining the patients' response to heparin during the surgery. The study will also look at the safety of Atenativ and any side effects that may occur.

Throughout the study, participants will be closely monitored by medical professionals. The study will involve several visits and follow-ups to ensure the safety and well-being of the participants. The results of this study could provide valuable information on the use of Atenativ in patients with heparin resistance undergoing heart surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient is confirmed to meet the inclusion criteria, which include being scheduled for cardiac surgery with cardiopulmonary bypass (CPB) and having heparin resistance.
The patient must be between 18 and 85 years old and provide informed consent. Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to surgery.
Step 2
Pre-surgery preparation
Before surgery, the patient receives an intravenous administration of 500 units per kilogram of body weight of unfractionated heparin (UFH).
The patient's activated clotting time (ACT) is measured between 2 and 5 minutes after heparin administration to confirm heparin resistance, defined as an ACT less than 480 seconds.
Step 3
Treatment administration
The patient is randomly assigned to receive either Atenativ or a placebo. Atenativ is a human plasma-derived antithrombin administered intravenously.
The study evaluates two different doses of Atenativ to determine its effectiveness in restoring and maintaining heparin responsiveness during surgery.
Step 4
During surgery
The patient undergoes cardiac surgery with CPB. The effectiveness of Atenativ or placebo in maintaining heparin responsiveness is monitored.
Additional therapies containing antithrombin may be administered if necessary to maintain heparin responsiveness.
Step 5
Post-surgery monitoring
After surgery, the patient is monitored for 24 hours to assess heparin responsiveness and any need for further antithrombin therapy.
The patient's recovery, including chest tube drainage and any need for reoperation due to bleeding, is evaluated.
Step 6
Follow-up and evaluation
The patient's survival status and any adverse events are recorded and compared across the different treatment groups.
The length of stay in the intensive care unit (ICU) and other recovery parameters are assessed to evaluate the overall effectiveness and safety of Atenativ.

Who can join the trial?

5 criteria

Patients must be planning to have heart surgery that uses a machine to help circulate blood, known as cardiopulmonary bypass (CPB).
Patients must have a condition called heparin resistance, which means their blood does not respond as expected to a medication called heparin. This is checked by a test called Hemochron ACT, which should show a result of less than 480 seconds after receiving a specific dose of heparin.
Patients must be between 18 and 85 years old.
Patients must provide written or electronic consent, meaning they agree to participate in the study after understanding what it involves.
Female patients who can have children must have a negative pregnancy test within 14 days before the surgery to ensure they are not pregnant.

Who cannot join the trial?

4 criteria

Patients who are not adults. This means anyone who is not fully grown or developed.
Patients who do not have the specific condition being studied, which is **Acquired Antithrombin Deficiency**. This is a condition where the body has low levels of a protein called antithrombin, which helps prevent blood clots, and it can cause resistance to a medication called heparin.
Patients who are not undergoing **cardiac surgery** with **cardiopulmonary bypass**. Cardiac surgery is an operation on the heart, and cardiopulmonary bypass is a technique that temporarily takes over the function of the heart and lungs during surgery.
Patients who are not experiencing **heparin resistance**. Heparin is a medication that prevents blood clots, and resistance means it is not working as well as it should.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Universitaire De Rennes
Verified
Rennes, France
Centre Hospitalier Universitaire Reims
Verified
Reims, France
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Responsive
Vilnius, Lithuania

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Investigated drugs

Atenativ is a medication derived from human plasma. It is used in this study to help patients who are resistant to heparin, a common blood thinner. The goal is to see if Atenativ can restore and maintain the effectiveness of heparin in patients undergoing heart surgery that requires the use of a heart-lung machine.

What is already known about the treatment

Atenativ – Atenativ is administered intravenously and is used to treat acquired antithrombin deficiency, particularly in patients who are resistant to heparin during cardiac surgery requiring cardiopulmonary bypass. Currently, it is being studied in a Phase 3 clinical trial to assess its effectiveness and safety. The main therapeutic indication is to restore and maintain heparin responsiveness in these patients. At the molecular level, Atenativ works by supplementing antithrombin, a protein that helps regulate blood clotting, thereby enhancing the anticoagulant effect of heparin. It is classified pharmacologically as an anticoagulant.

Investigated diseases

Acquired Antithrombin Deficiency (Heparin Resistance) – This condition occurs when the body has insufficient levels of antithrombin, a protein that helps regulate blood clotting. It can develop in patients undergoing procedures like cardiac surgery, where heparin, a blood thinner, is used to prevent clotting. In such cases, the deficiency leads to heparin resistance, meaning the usual doses of heparin are less effective. This can result in challenges during surgery, as maintaining proper blood flow and preventing clots becomes difficult. The condition is typically temporary and related to the specific medical situation, such as surgery. It requires careful management to ensure that blood clotting is controlled during and after the procedure.