Rôle of the Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State (EXERCISE) (EXERCISE)
Ex Vivo Study of the Role of Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Auvergne
-
Clermont-Ferrand, Auvergne, France, 63003
- Recruiting
- CHU de Clermont-Ferrand
-
Principal Investigator:
- Armand ABERGEL
-
Sub-Investigator:
- Aurélien LEBRETON
-
Sub-Investigator:
- Thomas SINEGRE
-
Sub-Investigator:
- Géraldine LAMBLIN
-
Sub-Investigator:
- Léon MUTI
-
Sub-Investigator:
- Camille TEILHET
-
Sub-Investigator:
- Maud REYMOND
-
Sub-Investigator:
- Cécile CAMPOS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Patients with cirrhosis
Inclusion criteria :
- Male, age 18 or older
- Cirrhosis, defined by: prothombin time ≤ 70% +/- liver dysmorphism +/- Fibroscan > 12.5 kPa +/- histology +/- portal hypertension associated with hepatocellular insufficiency
- Cirrhosis associated with hepatitis B or C, or alcoholic liver disease, or non alcoholic steato hepatitis
- Measurable portal flow by ultrasound doppler
- Child Pugh score A,B or C, without acute infection or acute bleeding
- Signed written informed consent
- Affiliation to french social security system
Exclusion criteria :
- Known history of vein thrombosis
- Known family history (in first-degree relative) of spontaneous thrombosis
- Partial or complete portal system vein thrombosis
- Uncontrolled infection after 7-day course of antibiotics
- Anticoagulant intake
- Hepatocellular carcinoma
- Protected or deprived of liberty adult
- Any medical or surgical history that could interfere with the study, as judged by the investigator
- Blood transfusion within 7 days
- Participation in a clinical trial for drug
Healthy volunteers
Inclusion criteria :
- Male, age 18 or older
- Body Mass Index between 18 and 30 kg/m2
- Normal physical examination
- Willing and able to comply with requirements of the study
- Agree to be registered in the french national registry for healthy volunteers
- Signed written informed consent
- Affiliation to french social security system
Exclusion criteria :
- Any medical or surgical history that could interfere with the study, as judged by the investigator
- Participation in a clinical trial for drug
- Protected or deprived of liberty adult
- Known history of vein thrombosis
- Known family history (in first-degree relative) of spontaneous thrombosis
- Anticoagulant intake
Patients with hepatocellular carcinoma (HCC)
Inclusion criteria :
- Male, age 18 or older
- Histological diagnosis of HCC, or use of BCLC criteria for diagnosis
- Treatment naïve HCC
- Measurable portal flow by ultrasound doppler
- For patients with cirrhosis: Child Pugh score A,B or C, without acute infection or acute bleeding
- Signed written informed consent
- Affiliation to french social security system
Exclusion criteria :
- Known history of vein thrombosis
- Known family history (in first-degree relative) of spontaneous thrombosis
- Partial or complete portal system vein thrombosis
- For patients with cirrhosis: uncontrolled infection after 7-day course of antibiotics
- Anticoagulant intake
- Protected or deprived of liberty adult
- Any medical or surgical history that could interfere with the study, as judged by the investigator
- Blood transfusion within 7 days
- Prior treated malignancy within the previous 2 years (except basal cell and squamous cell skin cancer, and superficial bladder cancer)
- Participation in a clinical trial for drug
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: patients with cirrhosis
pathophysiology study, blood sample
|
One blood sample.
|
|
Placebo Comparator: healthy volunteers
pathophysiology study, blood sample
|
One blood sample.
|
|
Placebo Comparator: patients with hepatocellular carcinoma
pathophysiology study, blood sample
|
One blood sample.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Thrombin generation assay (area under the curve/ Endogenous Thrombin Potential) with thrombomodulin.
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Thrombin generation assay parameters : peak height
Time Frame: 24 months
|
24 months
|
|
Thrombin generation assay parameters : lag time
Time Frame: 24 months
|
24 months
|
|
Thrombin generation assay parameters : time to peak
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Armand ABERGEL, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-403
- 2017-A00931-52 (Other Identifier: 2017-A00931-52)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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