Blood clotting and portal vein changes during TIPS placement in cirrhosis
Official title: Exploration of Systemic and Portal Hemostasis in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Placement
Run by Assistance Publique - Hôpitaux de Paris · NCT07439939 · Data updated 2026-11-12
This project will see how blood clotting in the body and in the portal vein changes in adults with cirrhosis who are having a TIPS placed.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Villejuif) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | June 9, 2027 |
| Study ends | June 9, 2027 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT07439939 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with cirrhosis who are followed at Paul Brousse and are scheduled for TIPS placement, covered by the required social security, and not receiving excluded hemostasis‑interfering treatments.
✕Probably not a fit
People without cirrhosis, those not undergoing TIPS, patients with known non-cirrhosis hemostatic disorders, those on interfering treatments that have not been stopped, or individuals lacking required social security coverage or under legal protection would not be expected to benefit or qualify.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center observational project enrolling adult patients with cirrhosis undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement at Hôpital Paul Brousse. Blood and portal samples will be collected around the time of the procedure to measure systemic and local hemostatic markers including platelet function, von Willebrand factor, factor VIII, coagulation and fibrinolysis factors, and markers of NETosis and inflammation. Portal vein wall changes and clinical variables related to portal hypertension and potential bacterial translocation will be recorded. The collected data will be analyzed to describe patterns that may relate to the development of portal vein thrombosis.
Why it matters
Potential benefit: If successful, this work could identify markers or mechanisms that help predict or prevent portal vein thrombosis in people with cirrhosis who undergo TIPS.
How similar studies have gone: Prior observational studies have described altered coagulation and endothelial markers in cirrhosis, but causal links to portal vein thrombosis and the role of bacterial translocation remain debated and not definitively proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (aged ≥18 years) covered by a social security scheme or entitled beneficiaries * Patients followed for a cirrhotic condition at Paul Brousse Hospital and undergoing placement of a TIPS (transjugular intrahepatic portosystemic shunt) Exclusion Criteria: * Patient unwilling to participate in the study * Patient with a contraindication to TIPS placement * Patient with a known hemostatic disorder unrelated to cirrhosis * Patient receiving treatment that interferes with hemostasis and has not been discontinued for the procedure * Patient receiving systemic corticosteroid therapy * Patient under legal protection * Patient not covered by a social security scheme
Where it's running
-
Hôpital Paul Brousse
Villejuif, France Recruiting
Study contacts
- Study coordinator: Stéphanie ROULLET stephanie.roullet@aphp.fr, PhD
- Email: stephanie.roullet@aphp.fr
- Phone: 145596949
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Coil-assisted small-diameter stent shunt reduction for refractory HE after TIPS
A coil-assisted, small-diameter covered-stent technique is being tested to see if it can safely and effectively reduce shunt flow and lessen recurrent hepatic encephalopathy in people with a prior TIPS.
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Austrian PBC Registry
This registry follows adults with primary biliary cholangitis in Austrian centers to see how the disease develops over time and how biomarkers relate to complications and symptoms.
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This study is testing if a procedure called TIPS can help people with liver cirrhosis and fluid buildup in their abdomen feel better compared to standard treatments like medications and draining the fluid.
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Using Ga-PSMA PET/MRI to assess liver cirrhosis
This study is testing a new imaging method to see if it can help doctors better understand liver function and damage in people with liver cirrhosis.
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Registry for patients undergoing TIPS implantation for portal hypertension
This study is collecting information from patients with serious portal hypertension who are getting a TIPS procedure to see how well it works and what complications might happen afterward.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.