Blood clotting and portal vein changes during TIPS placement in cirrhosis
Exploration of Systemic and Portal Hemostasis in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Placement
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 |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Villejuif) |
| Trial ID | NCT07439939 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Villejuif
- Hôpital Paul Brousse — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Stéphanie ROULLET stephanie.roullet@aphp.fr, PhD
- Email: stephanie.roullet@aphp.fr
- Phone: 145596949
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.