Chronic Liver DiseasesCLUENCT05865691
Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease
An observational study of Chronic Liver Diseases and Coagulation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Chronic liver diseases represent a major public health problem and are responsible for more than 150,000 deaths in Europe each year. These diseases are accompanied by symptoms that profoundly alter the quality of life and mainly affect people of working age, leading to a major economic impact. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Diseases, Coagulation
- What is being tested?
- biomarker assay
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2023to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age with chronic liver disease Controls without liver disease will be individuals over 18 years of age without liver disease
Who may be able to join
- Patients with chronic liver disease:
- Patients over 18 years of age Patients affiliated with a social security plan or entitled to receive benefits Patients with chronic liver disease or cirrhosis whose diagnosis is based on one or more of the following
- Liver biopsy showing chronic liver disease or cirrhosis
- Liver elastography by Fibroscan® assessing the elasticity of the liver at more than 10 kpa
- Combination of clinical, biological and imaging criteria characteristic of chronic liver disease (signs of portal hypertension, liver failure and liver dysmorphia in a patient with at least one risk factor for chronic liver disease)
- Controls without liver disease Patients 18 years of age with no known liver disease Patients who have had blood drawn in the hospital prior to surgery (pre-operative work-up as part of the care process).
Who cannot join
- Common non-inclusion criteria for patients with chronic liver disease and controls without liver disease will be as follows:
- Pregnant or lactating women
- Protected populations: persons under guardianship, under curatorship or safeguard of justice
- Patient under AME
- Patient who has not signed a consent form
- Recent surgery before the blood test (< 2 weeks)
Show all 10Show fewer
- Transfusion of blood products (packed red blood cells, platelet concentrates, fresh frozen plasma, etc.) recently (< 2 weeks)
- Use of medication that interferes with hemostasis
- Active extra-hepatic cancer or cancer less than 5 years old
- Organ transplantation (liver, kidney, lung, heart)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Beaujon Hospital
Clichy
Pierre emmanuel Rautou, pierre-emmanuel.rautou@aphp.fr
About this study
Chronic liver diseases represent a major public health problem and are responsible for more than 150,000 deaths in Europe each year. These diseases are accompanied by symptoms that profoundly alter the quality of life and mainly affect people of working age, leading to a major economic impact.
Coagulation disorders, inflammation and vascular alterations are associated with chronic liver diseases but their role in the onset and/or progression of liver diseases is still not fully understood.
A better understanding of chronic liver diseases and in particular of the factors that play a role in the onset and progression of these diseases would improve patient management and therefore have a positive impact on individuals, but also on the healthcare system and the economy.
Read the detailed description
Chronic liver diseases represent a major public health problem and are responsible for more than 150,000 deaths in Europe each year. These diseases are accompanied by symptoms that profoundly alter the quality of life and mainly affect people of working age, leading to a major economic impact.
Coagulation disorders, inflammation and vascular alterations are associated with chronic liver diseases but their role in the onset and/or progression of liver diseases is still not fully understood.
A better understanding of chronic liver diseases and in particular of the factors that play a role in the onset and progression of these diseases would improve patient management and therefore have a positive impact on individuals, but also on the healthcare system and the economy.
The main objective is to identify the role of coagulation in the development and progression of chronic liver diseases and their complications.
- Conditions
- Chronic Liver Diseases, Coagulation
- Being tested
- biomarker assay
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biomarker assayOther
Also called blood sample
blood sample on the day of inclusion
| Study group | Role | What they receive |
|---|---|---|
| controls without liver disease | blood collection on the day of inclusion Receives: Other: biomarker assay | |
| patients with chronic liver disease without cirrhosis | blood collection on the day of inclusion Receives: Other: biomarker assay | |
| patients with chronic liver disease with compensated cirrhosis | blood collection on the day of inclusion Receives: Other: biomarker assay | |
| patients with chronic liver disease with stable decompensated cirrhosis | blood collection on the day of inclusion Receives: Other: biomarker assay | |
| patients with chronic liver disease with decompensated cirrhosis in the acute phase | blood collection on the day of inclusion Receives: Other: biomarker assay | |
| patients with chronic liver disease with decompensated cirrhosis and organ failure | blood collection on the day of inclusion Receives: Other: biomarker assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activated partial thromboplastin time abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of activated partial thromboplastin time for each patient at inclusion
Measured: at 10 years
Factor II abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of factor II for each patient at inclusion
Measured: at 10 years
Factor V abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of factor V for each patient at inclusion
Measured: at 10 years
Factor VII abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of factor VII for each patient at inclusion
Measured: at 10 years
Factor VIII abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of factor VIII for each patient at inclusion
Measured: at 10 years
Factor IX abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of factor IX for each patient at inclusion
Measured: at 10 years
Factor X abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of factor X for each patient at inclusion
Measured: at 10 years
Factor XI abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of factor XI for each patient at inclusion
Measured: at 10 years
Fibrinogen abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of fibrinogen for each patient at inclusion
Measured: at 10 years
D-dimer abnormalities in patients with chronic liver disease at different stages and controls without liver disease
mesure of D-dimer for each patient at inclusion
Measured: at 10 years
Protein C abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of protein C for each patient at inclusion
Measured: at 10 years
protein S abnormalities in patients with chronic liver disease at different stages and controls without liver disease
mesure of protein S for each patient at inclusion
Measured: at 10 years
Willebrand factor abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of plasma Willebrand factor for each patient at inclusion
Measured: at 10 years
Thrombin generation test abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Mesure of thrombin generation test for each patient at inclusion
Measured: at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start7 Sep 2023
- Primary completion31 Oct 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Emmanuel Rautou, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865691
- Sponsor's protocol ID
- APHP220750
- Other IDs
- 2022-A01421-42
- Acronym
- CLUE
- Status last verified
- Jul 2024
- First submitted
- 24 Apr 2023
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Coagulation, Inflammation and Vessels in Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT05865691
- Acronym / sponsor ID
- CLUE / APHP220750
- Conditions
- Chronic Liver Diseases, Coagulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 31 Oct 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic liver diseases represent a major public health problem and are responsible for more than 150,000 deaths in Europe each year. These diseases are accompanied by symptoms that profoundly alter the quality of life and mainly affect people of working age, leading to a major economic impact.
Coagulation disorders, inflammation and vascular alterations are associated with chronic liver diseases but their role in the onset and/or progression of liver diseases is still not fully understood.
A better understanding of chronic liver diseases and in particular of the factors that play a role in the onset and progression of these diseases would improve patient management and therefore have a positive impact on individuals, but also on the healthcare system and the economy.
Detailed description
Chronic liver diseases represent a major public health problem and are responsible for more than 150,000 deaths in Europe each year. These diseases are accompanied by symptoms that profoundly alter the quality of life and mainly affect people of working age, leading to a major economic impact.
Coagulation disorders, inflammation and vascular alterations are associated with chronic liver diseases but their role in the onset and/or progression of liver diseases is still not fully understood.
A better understanding of chronic liver diseases and in particular of the factors that play a role in the onset and progression of these diseases would improve patient management and therefore have a positive impact on individuals, but also on the healthcare system and the economy.
The main objective is to identify the role of coagulation in the development and progression of chronic liver diseases and their complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| controls without liver disease | – | Other: biomarker assayblood collection on the day of inclusion |
| patients with chronic liver disease without cirrhosis | – | Other: biomarker assayblood collection on the day of inclusion |
| patients with chronic liver disease with compensated cirrhosis | – | Other: biomarker assayblood collection on the day of inclusion |
| patients with chronic liver disease with stable decompensated cirrhosis | – | Other: biomarker assayblood collection on the day of inclusion |
| patients with chronic liver disease with decompensated cirrhosis in the acute phase | – | Other: biomarker assayblood collection on the day of inclusion |
| patients with chronic liver disease with decompensated cirrhosis and organ failure | – | Other: biomarker assayblood collection on the day of inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age with chronic liver disease Controls without liver disease will be individuals over 18 years of age without liver disease
Key inclusion criteria (6 listed)
- Patients over 18 years of age Patients affiliated with a social security plan or entitled to receive benefits Patients with chronic liver disease or cirrhosis whose diagnosis is based on one or more of the following
- Liver biopsy showing chronic liver disease or cirrhosis
- Liver elastography by Fibroscan® assessing the elasticity of the liver at more than 10 kpa
- Combination of clinical, biological and imaging criteria characteristic of chronic liver disease (signs of portal hypertension, liver failure and liver dysmorphia in a patient with at least one risk factor for chronic liver disease)
- Controls without liver disease Patients 18 years of age with no known liver disease Patients who have had blood drawn in the hospital prior to surgery (pre-operative work-up as part of the care process).
Key exclusion criteria (10 listed)
- Common non-inclusion criteria for patients with chronic liver disease and controls without liver disease will be as follows:
- Pregnant or lactating women
- Protected populations: persons under guardianship, under curatorship or safeguard of justice
- Patient under AME
- Patient who has not signed a consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biomarker assayAlso: blood sampleblood sample on the day of inclusion | Other | controls without liver disease, patients with chronic liver disease with compensated cirrhosis, patients with chronic liver disease with decompensated cirrhosis and organ failure, patients with chronic liver disease with decompensated cirrhosis in the acute phase, patients with chronic liver disease with stable decompensated cirrhosis, patients with chronic liver disease without cirrhosis |
Primary outcome
Activated partial thromboplastin time abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
Mesure of activated partial thromboplastin time for each patient at inclusion
Factor II abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
Mesure of factor II for each patient at inclusion
Factor V abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
Mesure of factor V for each patient at inclusion
Factor VII abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
Mesure of factor VII for each patient at inclusion
Factor VIII abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
Mesure of factor VIII for each patient at inclusion
Factor IX abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
Mesure of factor IX for each patient at inclusion
Factor X abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
Mesure of factor X for each patient at inclusion
Factor XI abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
Mesure of factor XI for each patient at inclusion
Fibrinogen abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
Mesure of fibrinogen for each patient at inclusion
D-dimer abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
mesure of D-dimer for each patient at inclusion
Protein C abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
Mesure of protein C for each patient at inclusion
protein S abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
mesure of protein S for each patient at inclusion
Willebrand factor abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
Mesure of plasma Willebrand factor for each patient at inclusion
Thrombin generation test abnormalities in patients with chronic liver disease at different stages and controls without liver disease
Time frame: at 10 years
Mesure of thrombin generation test for each patient at inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Emmanuel Rautou principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Liver Diseases and Coagulation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Emmanuel Rautou (140875283 ext. +33, pierre-emmanuel.rautou@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activated partial thromboplastin time abnormalities in patients with chronic liver disease at different stages and controls without liver disease (time frame: at 10 years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.