An interventional study of Thrombin generation assay (in vitro) in Cirrhosis, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-30.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Screening
Cirrhosis is a condition in which the liver does not function properly due to long-term damage. This damage is characterized by the replacement of normal liver tissue by scar tissue.
The liver carries out several necessary functions, including synthesis of proteins participating in blood coagulation process. Some of these proteins contribute to coagulation and others make blood more fluid. In healthy people there is a balance between the two.
In cirrhotic patient, there is an imbalance inducing hypercoagulation (hypercoagulability state). Cirrhotic patients are so known to be at risk of vein thrombosis (for example portal vein thrombosis: clot in hepatic vein).
Mechanisms leading to this imbalance are unclear. Studies need to be completed to improve patient's management.
The EPCRs (Endothelial Protein C Receptor soluble) takes part in blood coagulation process. Previous studies have shown that blood levels of EPCRs are increased in patients with cirrhosis.
The primary purpose of the study is to evaluate if the EPCRs could play a role in cirrhosis-associated hypercoagulability state.
Three groups will be constitued: one with cirrhotic patients, one with healthy volunteers, and one with patients with hepatocellular carcinoma, a form of liver cancer (previous studies have also shown that blood levels of EPCRs are increased in these patients).
All participants will undergo a unique visit at hospital. An informed consent will be obtained before any related study procedures*.
* procedures: physical examination (including height, weight, waist measurement), vital signs (blood pressure, heart rate, temperature), medical history, concomitant medication, blood sample.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 300 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Patients with cirrhosis
Inclusion criteria :
Exclusion criteria :
Healthy volunteers
Inclusion criteria :
Exclusion criteria :
Patients with hepatocellular carcinoma (HCC)
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pathophysiology study, blood sample
Biological: Thrombin generation assay (in vitro)
pathophysiology study, blood sample
Biological: Thrombin generation assay (in vitro)
pathophysiology study, blood sample
Biological: Thrombin generation assay (in vitro)
One blood sample.
Thrombin generation assay (area under the curve/ Endogenous Thrombin Potential) with thrombomodulin.
Time frame: 24 months
Thrombin generation assay parameters : peak height
Time frame: 24 months
Thrombin generation assay parameters : lag time
Time frame: 24 months
Thrombin generation assay parameters : time to peak
Time frame: 24 months
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand