Informations générales (source: ClinicalTrials.gov)
Ex Vivo Study of the Role of Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State (EXERCISE)
Interventional
N/A
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
août 2018
août 2024
03 août 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de Clermont-Ferrand - 63003 - Clermont-Ferrand - Auvergne - France | Lise LACLAUTRE | Contact (sur clinicalTrials) | |||
Critères
Homme
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
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