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Study on Protamine Sulfate and Sodium Chloride to Reduce Bleeding in Patients with Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

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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 with aortic stenosis, a condition where the heart's aortic valve narrows, affecting blood flow. The study aims to compare two approaches: routine administration of protamine sulfate versus selective administration, to see which method better reduces bleeding complications after a procedure known as transcatheter aortic valve implantation (TAVI). TAVI is a minimally invasive procedure used to replace the aortic valve in patients with severe aortic stenosis.

Participants in the study will receive either routine or selective doses of protamine sulfate, which is used to counteract the effects of blood thinners and reduce bleeding. Another substance, sodium chloride, will also be used as a solution for injection or infusion during the study. The study will monitor the risk of cardiovascular mortality or bleeding within 30 days after the TAVI procedure, following specific criteria known as VARC-3. The goal is to determine which method of administering protamine sulfate is more effective in reducing these risks.

The study will take place over a period, with participants being observed for any bleeding complications, changes in hemoglobin levels, and other related outcomes. The trial will also assess the length of hospital stay after the procedure, the need for blood transfusions, and any major vascular complications. The findings from this study could help improve treatment strategies for patients undergoing TAVI, potentially leading to better outcomes and reduced risks of bleeding and other complications.

The research process

The trial runs in 5 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, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will need to provide written informed consent to participate.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are over 18 years old and are undergoing a procedure called transfemoral transcatheter aortic valve implantation (TAVI).
Step 3
Treatment administration
During the procedure, you will receive medications through an intravenous injection or infusion. The medications used are sodium chloride and protamine sulfate. The specific dosage and frequency will be determined by the medical team based on your individual needs.
Step 4
Monitoring and follow-up
After the procedure, you will be monitored for any bleeding complications or cardiovascular issues. This monitoring will continue for 30 days to assess the primary outcomes, which include cardiovascular mortality and bleeding events.
Step 5
Final assessment
At the end of the 30-day period, a final assessment will be conducted to evaluate your health status and any changes in your condition. This will include checking your hemoglobin levels and assessing any procedural or delayed bleeding complications.

Who can join the trial?

3 criteria

Must be over 18 years old.
Undergoing transfemoral TAVI (a procedure to replace a heart valve using a catheter inserted through the leg) with any commercially available transcatheter heart valve.
Must have provided written informed consent (agreed to participate in the study after being informed about it).

Who cannot join the trial?

3 criteria

Patients with a condition called aortic stenosis cannot participate. This is a narrowing of the heart's aortic valve.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.

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Verified sites

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

Academisch Ziekenhuis Leiden
Responsive
Leiden, The Netherlands
Algemeen Stedelijk Ziekenhuis Campus Aalst
Verified
Aalst, Belgium
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium

Trial locations

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Investigated drugs

Protamine is a medication used to reduce bleeding complications. In this clinical trial, it is being studied to see if giving it routinely, as opposed to selectively, can lower the risk of serious bleeding or death from heart-related issues within 30 days after a procedure called transcatheter aortic valve implantation (TAVI). Protamine works by reversing the effects of blood thinners, which are often used during surgeries to prevent blood clots. By doing this, it helps to control bleeding after the procedure.

What is already known about the treatment

Protamine – Protamine is administered through an injection, typically given intravenously, to counteract the effects of blood thinners like heparin. It is currently used in medical practice to manage bleeding complications, especially during procedures like transcatheter aortic valve implantation (TAVI). The main therapeutic indication for protamine is to reduce bleeding by neutralizing the anticoagulant effects of heparin. At the molecular level, protamine works by binding to heparin, forming a stable complex that prevents heparin from acting on the blood clotting process. It is classified pharmacologically as a heparin antagonist.

Investigated diseases

Aortic stenosis – Aortic stenosis is a condition where the aortic valve in the heart becomes narrowed. This narrowing restricts blood flow from the heart to the rest of the body. Over time, the heart must work harder to pump blood through the narrowed valve, which can lead to the thickening of the heart muscle. As the disease progresses, symptoms such as chest pain, fatigue, and shortness of breath may develop. In severe cases, it can lead to fainting or heart failure. The progression of aortic stenosis can vary, with some individuals experiencing rapid worsening of symptoms.