Rôle of the Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability Sta… (NCT03625726) | Clinical Trial Compass
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Rôle of the Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State (EXERCISE)
France300 participantsStarted 2018-08-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Thrombin generation assay (area under the curve/ Endogenous Thrombin Potential) with thrombomodulin.