Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Routine versus selective protamine administration to reduce bleeding complications after transcatheter aortic valve implantation

Doctors are studying whether a medicine called protamine can reduce bleeding problems after a heart procedure called TAVI. TAVI is short for Transcatheter Aortic Valve Implantation, and it's a way to replace a faulty heart valve. During the TAVI procedure, medicines are used to thin the blood, which can sometimes lead to bleeding afterwards. Protamine is given to reverse the effects of these blood-thinning medicines. This study is comparing giving protamine to all patients versus only giving it to patients who might need it. The main goal is to see if one approach is better at preventing serious bleeding and improving patients' health in the first month after the TAVI procedure.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

St Antonius Hospital

Enrolment target

800

Start

13 Jun 2023

Aortic stenosis

What is this study about?

This study is investigating a common heart condition called aortic stenosis, which means your heart's main valve doesn't open properly, making it harder for blood to flow. A procedure called TAVI (Transcatheter Aortic Valve Implantation) can help by replacing this faulty valve. During the TAVI procedure, doctors give you medicines to prevent blood clots. These blood thinners are very important, but they can sometimes cause bleeding afterwards.

To help prevent this bleeding, a medicine called protamine can be given. Protamine works by reversing the effects of the blood thinners. This study wants to find out if it's better to give protamine to all patients who have a TAVI procedure, or if it's better to only give it to certain patients based on their individual needs. The researchers are looking at how this affects serious bleeding and other health outcomes, including heart-related deaths, in the first month after the TAVI procedure.

By carefully comparing these two approaches, the study aims to make the TAVI procedure even safer and improve how patients recover. The results will help doctors decide the best way to use protamine for future patients undergoing TAVI, potentially reducing complications and improving their chances of a good recovery.

Key takeaways

The study investigates how best to prevent bleeding after TAVI.
It compares giving protamine to everyone versus only selected patients.
The main focus is on patient safety and recovery in the first 30 days.
Participants will undergo a TAVI procedure for aortic stenosis.
The findings aim to improve future care for TAVI patients.

Who may be eligible?

To join this study, you would generally need to be an adult, 18 years or older, who is about to have a TAVI procedure for aortic stenosis. The study is open to both men and women.

As with any clinical study, there will be specific medical conditions, current medications, or other health factors that might mean the study isn't suitable for you. This is to ensure your safety and that the study results are clear.

Your doctor will discuss all the detailed requirements with you to see if you are a good fit for this research. They will make sure it's the right choice for your health and treatment plan.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for a TAVI procedure for aortic stenosis?
Are you able to attend routine follow-up appointments as advised by your doctor?
Are you comfortable with the study team collecting information about your health after your TAVI?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo your planned TAVI procedure as usual. The main difference would be whether you receive the protamine medicine after the procedure, based on the study's design. Some participants will receive protamine, while others might receive a saline (saltwater) solution, or have protamine given only if their doctor deems it necessary.

You would have regular check-ups and assessments, similar to what you would normally have after a TAVI procedure, to monitor your health and recovery. The study specifically looks at your progress for 30 days after the TAVI procedure, focusing on any bleeding, other complications, or how you're feeling. This would primarily involve doctors and nurses gathering information from your medical records and your usual follow-up appointments.

Potential risks and benefits

Taking part in a study like this could potentially help improve care for future patients undergoing TAVI. For you, there's a chance that the way protamine is given might reduce your risk of bleeding, but this isn't guaranteed. All medical interventions carry some risks, and protamine, like any medicine, can have side effects, though serious reactions are rare. You have the right to withdraw from the study at any time without giving a reason, and this would not affect your ongoing medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands
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Unverified
Belgium

Common questions

What is aortic stenosis?

Aortic stenosis is a heart condition where the main valve in your heart (the aortic valve) becomes stiff and doesn't open fully, making it harder for blood to flow out to your body.

What is TAVI?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a keyhole procedure to replace a faulty aortic valve without needing open-heart surgery.

What is protamine?

Protamine is a medicine given to reverse the effects of blood-thinning drugs that are often used during heart procedures like TAVI, to help reduce the risk of bleeding.

Will I definitely get protamine if I join the study?

Not necessarily. The study is comparing different ways of giving protamine, so you might receive it, or your doctor might decide based on your specific needs, or you might receive a plain saltwater solution if that's part of the comparison.

How long will I be involved in the study?

The main part of this study involves looking at your health outcomes, particularly any bleeding or complications, for just 30 days after your TAVI procedure.