Rôle of the Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State (EXERCISE)
NCT ID: NCT03625726
Last Updated: 2022-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2018-08-03
2024-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
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patients with cirrhosis
pathophysiology study, blood sample
Thrombin generation assay (in vitro)
One blood sample.
healthy volunteers
pathophysiology study, blood sample
Thrombin generation assay (in vitro)
One blood sample.
patients with hepatocellular carcinoma
pathophysiology study, blood sample
Thrombin generation assay (in vitro)
One blood sample.
Interventions
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Thrombin generation assay (in vitro)
One blood sample.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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 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
* 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)
* 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
18 Years
MALE
Yes
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Armand ABERGEL
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-A00931-52
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-403
Identifier Type: -
Identifier Source: org_study_id
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