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NCT07439939Recruiting

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

Source: ClinicalTrials.gov · Last updated 21 Apr 2026

Brief summary (registry, in English)

Portal vein thrombosis is defined as non-tumoural obstruction of the portal vein or one of its branches. Its incidence is 0.7 to 2.7 per 100,000 patient-years in the general population, and 4.6 per 100 patient-years in patients with cirrhosis. Histological modificaitions fo the portal vein wall and haemostatic changes have been described in cirrhotic patients. The contribution of these changes, both systemic and local, to the development of portal vein thrombosis is debated. One of the hypotheses put forward on the genesis of portal vein thrombosis is as follows: certain bacterial translocations from the digestive tract, promoted by portal hypertension, contribute to endothelial activation resulting in the release of von Willebrand factor and factor VIII, as well as platelet activation and the coagulation cascade, which is dysregulated by cirrhosis and underlying changes in haemostatic balance. Inflammatory phenomena and NETosis may also be involved. Studies suggest that cirrhotic patients have lesions of the glycocalyx located in the portal area, which may be involved in the development of portal vein thrombosis. Patients with cirrhosis may benefit from the placement of a transjugular intrahepatic portosystemic shunt (TIPS). During the TIPS placement procedure, blood is drawn from the internal jugular vein and the portal vein, allowing for parallel biological analyses. The assumption of this study is that haemostasis and inflammation are disrupted differently at the systemic and portal levels in cirrhotic patients.

Status (registry)
Recruiting
Study type
Observational
Enrollment
45 (estimated)
First submitted
19 Jan 2026
Start date
9 Mar 2026
Primary completion date
9 Jun 2027
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT07439939

What you commit to

  • Study type: Observational
  • Planned participants: 45
  • From 9 Mar 2026 to the primary completion date, 9 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient receiving treatment that interferes with hemostasis and has not been discontinued for the procedure
  • Patient receiving systemic corticosteroid therapy

Other illness

  • Patient with a known hemostatic disorder unrelated to cirrhosis

Other

  • Patient unwilling to participate in the study
  • Patient with a contraindication to TIPS placement
  • Patient under legal protection
  • Patient not covered by a social security scheme

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpital Paul-Brousse
Coordinator of this site? Confirm its status
VillejuifFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.