Exploration of Systemic and Portal Hemostasis in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Placement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis, Portal Hypertension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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. Portal vein thrombosis associated with cirrhosis, which is most often non-occlusive (70%), is characterised by histological changes in the portal vein wall and the presence of an intraluminal thrombus.
In cirrhotic patients, histological changes are described at the portal level. In response to portal hypertension, the calibre of the portal vein, where circulation is at low pressure and high compliance, increases. In response to this mechanical stress, intimal hypertrophy and fibroblast proliferation are observed. In cases of portal vein thrombosis, these changes are more pronounced. Changes in haemostatic balance are also observed in these patients. Thrombocytopenia and decreased synthesis of coagulation factors on the one hand, and decreased coagulation cascade and fibrinolytic regulatory factors on the other, contribute to creating a new fragile haemostatic balance. 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 (VWF) and factor VIII, as well as platelet activation and the coagulation cascade, which is dysregulated by cirrhosis and underlying changes in haemostatic balance.
This hypothesis is supported by several studies showing that cirrhotic patients have higher portal than systemic levels of VWF, factor VIII and lipopolysaccharides. Inflammatory phenomena and NETosis may also be involved.
The vascular endothelial surface is covered by the glycocalyx, with antithrombotic and anti-inflammatory effects that regulates vascular permeability. The endothelial glycocalyx has three major components: proteoglycans binding to the endothelial membrane, sulphated glycosaminoglycans bound laterally to proteoglycans, and plasma proteins. 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. To our knowledge, studies conducted to date have not investigated haemostasis under flow conditions, which are more physiological than static investigations.
Primary outcome measures
- Area Under the Curve (AUC) of primary hemostasis assessed by T-TAS®01 at 10 minutes [Time frame: At 10 minutes of perfusion during the T-TAS®01 primary hemostasis assessment procedure]
Secondary outcome measures (12)
- Time to reach 10 kPa above baseline pressure in the T-TAS®01 system [Time frame: At the time of TIPS placement]
- Time to reach 60 kPa above baseline pressure in the T-TAS®01 system [Time frame: At the time of TIPS placement]
- Conventional coagulation parameters at systemic and portal levels [Time frame: At the time of TIPS placement]
- Fibrinolysis parameters at systemic and portal levels [Time frame: At the time of TIPS placement]
- Complete blood count parameters at systemic and portal levels [Time frame: At the time of TIPS placement]
- ROTEM® coagulation parameters at systemic and portal levels [Time frame: At the time of TIPS placement]
- Thrombin generation parameters at systemic and portal levels [Time frame: At the time of TIPS placemen]
- Inflammatory biomarkers at systemic and portal levels [Time frame: At the time of TIPS placement]
- Endothelial and glycocalyx biomarkers at systemic and portal levels [Time frame: At the time of TIPS placement]
- Markers of thrombo-inflammation and NETosis at systemic and portal levels [Time frame: At the time of TIPS placement]
- Child-Pugh score [Time frame: Prior to TIPS placement]
- MELD score [Time frame: Prior to TIPS placement]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Paul Brousse — Villejuif
Identifiers
NCT: NCT07439939 · APHP251320 · 2025-A02001-48