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

NCT07439939 | Recruiting

• 2 other identifiers: APHP2513202025-A02001-48
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Portal Hypertension

Keywords

liver cirrhosis; portal hypertension; Transjugular Intrahepatic Portosystemic Shunt; Primary Hemostasis; Blood Coagulation; Fibrinolysis; Thromboinflammation; von Willebrand Factor; Endothelial Dysfunction; Portal Circulation

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of primary hemostasis assessed by T-TAS®01 at 10 minutes

  The primary outcome measure is the area under the curve (AUC) obtained at 10 minutes of perfusion during the assessment of primary hemostasis using the T-TAS®01 microfluidic system. Measurements are performed with PL chips coated with collagen. Under these conditions, thrombus formation is dependent on von Willebrand factor, allowing evaluation of primary hemostasis at the systemic and portal levels in patients with cirrhosis.

  At 10 minutes of perfusion during the T-TAS®01 primary hemostasis assessment procedure

Secondary Outcomes (16)

• Time to reach 10 kPa above baseline pressure in the T-TAS®01 system

  At the time of TIPS placement

• Time to reach 60 kPa above baseline pressure in the T-TAS®01 system

  At the time of TIPS placement

• Conventional coagulation parameters at systemic and portal levels

  At the time of TIPS placement

• Fibrinolysis parameters at systemic and portal levels

  At the time of TIPS placement

• Complete blood count parameters at systemic and portal levels

  At the time of TIPS placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cirrhosis, regardless of the underlying cause, undergoing TIPS placement, regardless of the indication.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Paul Brousse

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Hypertension, Portal; Thrombosis; Thromboinflammation

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Inflammation

Central Study Contacts

Stéphanie ROULLET stephanie.roullet@aphp.fr, PhD

CONTACT

145596949; stephanie.roullet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 27, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): June 9, 2027
• Study Completion (Estimated): June 9, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-02

Locations

FR (1)