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Study on Protamine Sulfate to Reduce Neurological Events After Aortic Valve Implantation in Patients with Aortic Stenosis

Verified siteRegistered drugNo placebo
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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 studying the effects of a medication called protamine sulfate in patients undergoing a procedure known as transcatheter aortic valve implantation (TAVI) for a condition called aortic stenosis. Aortic stenosis is a heart condition where the valve that controls blood flow from the heart to the rest of the body becomes narrowed, making it difficult for the heart to pump blood. The study aims to see if using protamine sulfate can reduce complications such as bleeding, stroke, and other heart-related issues after the TAVI procedure.

During the study, participants will receive either protamine sulfate or the usual care after their TAVI procedure. The medication is given as an injection into a vein. The study will monitor participants from the time of the procedure until they are discharged from the hospital. Researchers will look at various outcomes, including the occurrence of any serious events like death, bleeding, or the need for a blood transfusion, to determine if protamine sulfate provides better results compared to the usual care.

The purpose of this study is to demonstrate whether systematic use of protamine sulfate can improve patient outcomes by reducing in-hospital mortality and complications related to the TAVI procedure. The study will continue until early 2026, with the goal of providing valuable insights into the potential benefits of protamine sulfate in this specific medical setting.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the details and purpose of the study.

    You must be at least 18 years old and eligible for a procedure called transfemoral TAVI, which is a treatment for aortic stenosis. You should also be registered with the French social healthcare system.

  2. Step 2

    Randomization

    After joining, you will be randomly assigned to one of two groups. One group will receive the usual care, and the other group will receive a medication called protamine sulfate.

  3. Step 3

    Treatment administration

    If you are in the group receiving protamine sulfate, it will be administered through an intravenous injection. This means the medication will be given directly into your vein.

    The purpose of this medication is to reduce the risk of complications such as bleeding or stroke after your TAVI procedure.

  4. Step 4

    Monitoring and follow-up

    Throughout your hospital stay, you will be closely monitored for any signs of complications. This includes checking for bleeding, stroke, or any other health issues.

    The study aims to assess the effectiveness of protamine sulfate in reducing these risks compared to the usual care.

  5. Step 5

    Discharge and final assessment

    Before you are discharged from the hospital, a final assessment will be conducted to evaluate your health status and any events that occurred during your stay.

    The results of this assessment will contribute to the study's findings on the safety and effectiveness of the treatment.

Who can join the trial?

4 criteria

  • Men and women who are 18 years old or older.
  • Any patient who is eligible for transfemoral TAVI (a procedure to replace a heart valve through a blood vessel in the leg), regardless of their ongoing treatment to prevent blood clots.
  • Must provide written informed consent, which means you agree to participate after being fully informed about the study.
  • Must be registered with the French social healthcare system.

Who cannot join the trial?

3 criteria

  • Patients who are under 18 years old cannot participate.
  • Patients who are not eligible for transfemoral TAVI cannot participate. Transfemoral TAVI is a procedure to replace a heart valve using a tube inserted through a blood vessel in the leg.
  • Patients without medical insurance coverage cannot participate.
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Investigated drugs

Protamine sulfate is a medication used in this clinical trial to counteract the effects of heparin, a blood thinner. After certain heart procedures, like transcatheter aortic valve implantation, it's important to stop the blood-thinning effects of heparin to prevent bleeding complications. Protamine sulfate works by neutralizing heparin, helping to reduce the risk of bleeding and other complications, such as stroke or heart attack, during the recovery period in the hospital.

What is already known about the treatment

Protamine sulfate – Protamine sulfate is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials to assess its effectiveness in reducing complications after heart valve procedures. The main therapeutic use of protamine sulfate is to counteract the effects of heparin, a blood thinner, to prevent excessive bleeding. At the molecular level, protamine sulfate works by binding to heparin, neutralizing its anticoagulant properties. It is classified as an antidote in pharmacology, specifically used to reverse the effects of heparin.

Investigated diseases

  • Stroke

    Stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can happen due to a blocked artery (ischemic stroke) or leaking or bursting of a blood vessel (hemorrhagic stroke). Brain cells begin to die within minutes, leading to potential loss of function in the affected area. Symptoms may include trouble speaking, paralysis or numbness of the face, arm, or leg, and problems seeing in one or both eyes. The progression of a stroke can lead to significant neurological damage if not addressed promptly. Recovery and progression vary depending on the severity and location of the stroke.

  • Myocardial Infarction

    Myocardial infarction, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. This is usually due to a blockage in one or more of the coronary arteries. Symptoms often include chest pain or discomfort, which may radiate to the shoulder, arm, back, neck, or jaw. Other symptoms can include shortness of breath, nausea, and cold sweats. The progression of myocardial infarction can lead to heart muscle damage, affecting the heart's ability to pump blood effectively. The extent of damage depends on the size and location of the blockage.

  • Transient Ischemic Attack (TIA)

    A transient ischemic attack, often called a mini-stroke, occurs when there is a temporary decrease in blood supply to part of the brain. This results in stroke-like symptoms that last less than 24 hours before disappearing. Common symptoms include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, and loss of balance or coordination. Unlike a full stroke, a TIA does not cause permanent damage to the brain. However, it is a warning sign that a person is at risk for a future stroke. The progression of a TIA is typically rapid, with symptoms resolving quickly, but it requires medical evaluation to prevent future events.

  • Vascular Complications

    Vascular complications refer to problems that occur in the blood vessels, which can arise from various medical procedures or conditions. These complications can include bleeding, clot formation, or injury to the blood vessels. Symptoms may vary depending on the type and location of the complication but can include pain, swelling, and changes in skin color. The progression of vascular complications can lead to further health issues if not managed properly. They are often associated with procedures like catheterization or surgery, where blood vessels are accessed or manipulated. Monitoring and management are crucial to prevent further complications.

  • Bleeding Complications

    Bleeding complications involve excessive or uncontrolled bleeding, which can occur internally or externally. These complications can arise from surgical procedures, trauma, or certain medical conditions that affect blood clotting. Symptoms may include visible bleeding, bruising, or signs of internal bleeding such as dizziness or weakness. The progression of bleeding complications can lead to significant blood loss and require medical intervention. They are often classified by severity, with more severe cases potentially leading to further health issues. Monitoring and timely management are essential to control bleeding and prevent further complications.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504511-32-00Protocol codeAPHP211046Estimated enrolment940 patientsSponsorAssistance Publique Hopitaux De Paris

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