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Exploration of Systemic and Portal Hemostasis in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Placement

This study is investigating why some individuals with liver cirrhosis, a condition where the liver is scarred, develop blood clots in the portal vein, which is a key blood vessel supplying the liver. This issue, called portal vein thrombosis, can be serious. Doctors don't fully understand why these clots form in people with cirrhosis, but it's thought to be linked to changes in how blood clots and how the body handles inflammation. Researchers are taking blood samples from different parts of the body during a procedure called a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. This procedure helps relieve pressure in the liver. By comparing blood samples from the main body circulation and directly from the liver's portal vein, the study hopes to find clues about what causes these clots. The aim is to better understand these differences, which could eventually lead to improved ways of preventing or treating portal vein thrombosis.

At a glance

Status
Recruiting
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrolment target
45
Start
09 Mar 2026
Estimated completion
09 Jun 2027

What is this study about?

This study is looking into a problem called portal vein thrombosis, which is when a blood clot forms in the portal vein – a main blood vessel that carries blood to your liver. This condition can be more common in people who have liver cirrhosis, which is a type of scarring of the liver. While we know that cirrhosis can make developing blood clots more likely, doctors are still trying to understand exactly why and how these clots form specifically in the portal vein.

One idea is that having cirrhosis changes how your body's blood clotting system works, and it might also affect how your body deals with inflammation. Some researchers believe that tiny bits of bacteria from your gut might sometimes move into your bloodstream if you have high pressure in your liver (which is common in cirrhosis). This could trigger changes in the lining of your blood vessels, leading to a higher risk of clots forming.

To investigate this, the study will collect blood samples during a medical procedure called a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement. A TIPS is a small tube placed in the liver that helps reduce high blood pressure in the liver. During this procedure, doctors can safely collect blood from both the main circulation in your body (from a vein in your neck) and directly from the portal vein in your liver. By comparing these blood samples, the researchers hope to learn how blood clotting and inflammation behave differently in the liver itself compared to the rest of the body in people with cirrhosis. This could help us understand the root causes of portal vein thrombosis.

Key takeaways

  • This study investigates why blood clots form in the portal vein in people with liver cirrhosis.
  • It aims to understand differences in blood clotting and inflammation between the liver and the rest of the body.
  • Blood samples will be taken during a routine TIPS procedure.
  • Participation involves no extra visits, medications, or follow-up appointments.
  • The findings could help improve future prevention or treatment of portal vein clots.

Who may be eligible?

This study is for adults aged 18 or over who have liver cirrhosis and are already scheduled to have a TIPS procedure at Paul Brousse Hospital.

There are several reasons why someone might not be able to join the study. This includes if you don’t want to take part, or if you have another medical reason that means you can't have a TIPS procedure. You also can't participate if you have a known blood clotting problem that isn't related to your cirrhosis, or if you're taking medications that affect blood clotting and these can't be stopped for the procedure. People on certain steroid medications are also not eligible.

Additionally, if you are under special legal protection (for example, if you have a guardian) or if you are not covered by the national health scheme, you won't be able to join. The researchers want to make sure the study includes people who can fully understand and agree to take part, and that their participation is medically appropriate.

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.

  1. Are you 18 years old or older?
  2. Do you have liver cirrhosis?
  3. Are you scheduled for a TIPS procedure at Paul Brousse Hospital?
  4. Do you *not* have another blood clotting disorder unrelated to your cirrhosis?
  5. Are you *not* taking medications that affect blood clotting that cannot be stopped for the procedure?
  6. Are you able to agree to take part in the study yourself?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need any extra hospital visits or special appointments beyond what's already planned for your TIPS procedure. The study only involves collecting a few extra blood samples during your TIPS placement. You won't be asked to take any new medications or undergo any additional tests specially for the study. There will be no follow-up appointments related to the study itself. Your involvement would be a one-off event during your hospital stay for the TIPS procedure.

Potential risks and benefits

While participating in this study might not offer direct personal benefits, the information gathered could help doctors better understand portal vein thrombosis in people with cirrhosis. This could lead to improved prevention or treatment strategies in the future. The main risk is the collection of additional blood samples during your TIPS procedure, which is generally very safe, but carries a tiny risk of bruising or discomfort, similar to any blood test. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

  • Hôpital Paul Brousse
    Verified postcode
    Villejuif, France· Recruiting

Common questions

What is the portal vein?

The portal vein is a large blood vessel that carries blood from your digestive organs to your liver. It's very important for your liver to work properly.

What is liver cirrhosis?

Liver cirrhosis is a condition where your liver is badly scarred, which can make it difficult for your liver to work as it should.

What is a TIPS procedure?

A TIPS (Transjugular Intrahepatic Portosystemic Shunt) is a procedure to place a small tube in your liver. It helps to lower high blood pressure in the liver that can happen with cirrhosis.

Will taking part in the study change my medical treatment?

No, taking part in this study will not change your medical treatment or the care you receive for your cirrhosis or TIPS procedure.

How much extra blood will be taken?

Only a small amount of extra blood will be collected during your TIPS procedure, similar to what's taken for routine blood tests.

How to find out more

Stéphanie ROULLET stephanie.roullet@aphp.fr, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Exploration of Systemic and Portal Hemostasis in Patients Un…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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