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Rôle of the Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State (EXERCISE) (EXERCISE)

Primary Purpose

Cirrhosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Thrombin generation assay (in vitro)
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cirrhosis focused on measuring cirrhosis, hypercoagulability, thrombin generation assay, soluble Endothelial Protein C Receptor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

patients with cirrhosis

healthy volunteers

patients with hepatocellular carcinoma

Arm Description

pathophysiology study, blood sample

pathophysiology study, blood sample

pathophysiology study, blood sample

Outcomes

Primary Outcome Measures

Thrombin generation assay (area under the curve/ Endogenous Thrombin Potential) with thrombomodulin.

Secondary Outcome Measures

Thrombin generation assay parameters : peak height
Thrombin generation assay parameters : lag time
Thrombin generation assay parameters : time to peak

Full Information

First Posted
July 30, 2018
Last Updated
August 29, 2022
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03625726
Brief Title
Rôle of the Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State (EXERCISE)
Acronym
EXERCISE
Official Title
Ex Vivo Study of the Role of Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
Keywords
cirrhosis, hypercoagulability, thrombin generation assay, soluble Endothelial Protein C Receptor

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Exploratory, cross-sectional, case-control pathophysiology study, based on ex vivo treatment of blood samples.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with cirrhosis
Arm Type
Experimental
Arm Description
pathophysiology study, blood sample
Arm Title
healthy volunteers
Arm Type
Placebo Comparator
Arm Description
pathophysiology study, blood sample
Arm Title
patients with hepatocellular carcinoma
Arm Type
Placebo Comparator
Arm Description
pathophysiology study, blood sample
Intervention Type
Biological
Intervention Name(s)
Thrombin generation assay (in vitro)
Intervention Description
One blood sample.
Primary Outcome Measure Information:
Title
Thrombin generation assay (area under the curve/ Endogenous Thrombin Potential) with thrombomodulin.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Thrombin generation assay parameters : peak height
Time Frame
24 months
Title
Thrombin generation assay parameters : lag time
Time Frame
24 months
Title
Thrombin generation assay parameters : time to peak
Time Frame
24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
04 73 75 49 63
Email
drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armand ABERGEL
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise LACLAUTRE
Phone
04 73 75 49 63
Email
drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Armand ABERGEL
First Name & Middle Initial & Last Name & Degree
Aurélien LEBRETON
First Name & Middle Initial & Last Name & Degree
Thomas SINEGRE
First Name & Middle Initial & Last Name & Degree
Géraldine LAMBLIN
First Name & Middle Initial & Last Name & Degree
Léon MUTI
First Name & Middle Initial & Last Name & Degree
Camille TEILHET
First Name & Middle Initial & Last Name & Degree
Maud REYMOND
First Name & Middle Initial & Last Name & Degree
Cécile CAMPOS

12. IPD Sharing Statement

Learn more about this trial

Rôle of the Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State (EXERCISE)

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