NCT07439939 Exploration of Systemic and Portal Hemostasis in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Placement
| NCT ID | NCT07439939 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Liver Cirrhosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2027-06-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2026-03-09 with a primary completion date of 2027-06-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07439939 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07439939 currently recruiting?
Yes, NCT07439939 is actively recruiting participants. Contact the research team at stephanie.roullet@aphp.fr for enrollment information.
Where is the NCT07439939 trial being conducted?
This trial is being conducted at Villejuif, France.
Who is sponsoring the NCT07439939 clinical trial?
NCT07439939 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 45 participants.