CirrhosisEXERCISENCT03625726
Rôle of the Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State (EXERCISE)
A study testing Thrombin generation assay (in vitro) in people with Cirrhosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Thrombin generation assay (in vitro)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 3 Aug 2018to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Lise LACLAUTRE, 04 73 75 49 63, drci@chu-clermontferrand.fr
Armand ABERGEL
About this study
Official title: Ex Vivo Study of the Role of Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State
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.
Read more
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.
Read the 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.
- Conditions
- Cirrhosis
- Being tested
- Thrombin generation assay (in vitro)
- Keywords
- cirrhosis, hypercoagulability, thrombin generation assay, soluble Endothelial Protein C Receptor
- Medical subject headings
- Fibrosis, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombin generation assay (in vitro)Biological
One blood sample.
| Study group | Role | What they receive |
|---|---|---|
| patients with cirrhosis | Experimental | pathophysiology study, blood sample Receives: Biological: Thrombin generation assay (in vitro) |
| healthy volunteers | Placebo comparator | pathophysiology study, blood sample Receives: Biological: Thrombin generation assay (in vitro) |
| patients with hepatocellular carcinoma | Placebo comparator | pathophysiology study, blood sample Receives: Biological: Thrombin generation assay (in vitro) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombin generation assay (area under the curve/ Endogenous Thrombin Potential) with thrombomodulin.
Measured: 24 months
Secondary outcomes (3)
Thrombin generation assay parameters : peak height
Measured: 24 months
Thrombin generation assay parameters : lag time
Measured: 24 months
Thrombin generation assay parameters : time to peak
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start3 Aug 2018
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Exploratory, cross-sectional, case-control pathophysiology study, based on ex vivo treatment of blood samples.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armand ABERGEL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625726
- Sponsor's protocol ID
- CHU-403
- Other IDs
- 2017-A00931-52
- Acronym
- EXERCISE
- Status last verified
- Aug 2022
- First submitted
- 30 Jul 2018
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Study of the Role of Soluble Endothelial Protein C Receptor in Cirrhosis-associated Hypercoagulability State
- ClinicalTrials.gov ID
- NCT03625726
- Acronym / sponsor ID
- EXERCISE / CHU-403
- Conditions
- Cirrhosis
- Keywords
- cirrhosis, hypercoagulability, thrombin generation assay, soluble Endothelial Protein C Receptor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 10 Aug 2018 (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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Exploratory, cross-sectional, case-control pathophysiology study, based on ex vivo treatment of blood samples.
| Arm | Type | Receives |
|---|---|---|
| patients with cirrhosis | Experimental | Biological: Thrombin generation assay (in vitro)pathophysiology study, blood sample |
| healthy volunteers | Placebo comparator | Biological: Thrombin generation assay (in vitro)pathophysiology study, blood sample |
| patients with hepatocellular carcinoma | Placebo comparator | Biological: Thrombin generation assay (in vitro)pathophysiology study, blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (28 listed)
- 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
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 |
|---|---|---|
| Thrombin generation assay (in vitro)One blood sample. | Biological | healthy volunteers, patients with cirrhosis, patients with hepatocellular carcinoma |
Primary outcome
Thrombin generation assay (area under the curve/ Endogenous Thrombin Potential) with thrombomodulin.
Time frame: 24 months
3 secondary outcomes
Thrombin generation assay parameters : peak height
Time frame: 24 months
Thrombin generation assay parameters : lag time
Time frame: 24 months
Thrombin generation assay parameters : time to peak
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
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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. This study is not recruiting at the moment.
Armand ABERGEL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombin generation assay (in vitro) in people with Cirrhosis, run by University Hospital, Clermont-Ferrand 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 21 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 30 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (04 73 75 49 63, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombin generation assay (area under the curve/ Endogenous Thrombin Potential) with thrombomodulin. (time frame: 24 months). 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 30 Aug 2022.