Liver CirrhosisMicroCirNCT02859610
Microparticles in Cirrhosis and Portal Hypertension
A study testing research on interactions between portal hypertension and microparticles in people with Liver Cirrhosis and Portal Hypertension, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
research on interactions between portal hypertension and microparticles Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension
- What is being tested?
- research on interactions between portal hypertension and microparticles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2015
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non infected cirrhotic patient (30 patients Child-Pugh A, 30 Child-Pugh B et 30 Child-Pugh C).
- 10 heathly volunteer (groupe contrôle).
Who cannot join
- legal incapacity or limited legal capacity
- Subject unlikely to cooperate in the study and / or low early cooperation by the investigator
- Subject without health insurance
- Pregnant woman
- About being in the disqualification of another study or under the "national register of volunteers."
- Any proven or suspected infection
Show all 12Show fewer
- Pre-hepatic portal hypertension (door thrombosis) or post-liver (Budd-Chiari) transplant patients, HIV infection (also refusing HIV status) or patients on immunosuppressive therapies (including corticosteroids) interferon taken
- Treatment with anticoagulants or antiplatelet upper gastrointestinal bleeding in the two months prior
- Patients with TIPS
- Any cancer pathology proven and current.
- Chronic heart failure (stage III or IV of the classification of the New York Heart Association [NYHA])
- Inability to receive clear information in patients with severe encephalopathy and do not have someone you trust
About this study
Official title: Characterization of Microparticles in Cirrhosis and Portal Hypertension With Implications
research on interactions between portal hypertension and microparticles
Read the detailed description
It has already been shown that increased certain markers of stress, such as prolonged elevation of CRP in the absence of bacterial infection, increased free cortisol and serum copeptin, are associated with an excess of mortality in cirrhosis.
MPs are membrane vesicles of variable size between 0.1 and 1 .mu.m, released into the extracellular space following activation or cellular apoptosis. MPs are also found in the circulating blood of healthy volunteers and their plasma levels rise in certain diseases to increased thrombotic risk, such as in cancer. Their membrane is composed of antigens whose organization is characteristic of the parent cell and negatively charged phospholipids, phosphatidylserines, conferring pro-coagulant properties to these MPs.
Currently, work on the MPs are increasing following the discovery of their involvement in physiological processes such as proliferation, differentiation, cell activation and immune response but it is certainly their pro-thrombogenic power that was the most studied.
Recent studies have also implicated MPs in the pathophysiology of chronic liver disease. Cirrhotic patients have elevated concentrations of MPs from leukocytes, endothelial cells and hepatocytes compared to control subjects, and concentrations of MPs increase with worsening liver function. Increasing MPs during the cirrhosis may be related on the one hand with a decreased clearance and secondly with an excess of proinflammatory cytokines by increasing the phenomenon of intestinal bacterial translocation. The assumption of the role of systemic inflammation in the training of MPs is reinforced by the existence of a significant correlation between the original MPs hepatocyte or buffy endothelial and CRP Thus, the increase in MPs observed with the increase of PH could increase the risk of thrombosis in intestinal microcirculation leading to enterocytic suffering from ischemic, reflected by an increase in serum concentrations of I-FABP ( intestinal fatty acid binding protein). This suffering enterocytes leads to increased intestinal bacterial translocation and ultimately to increased formation of MPs. These MPs could also worsen liver function by the same phenomenon of thrombosis in the hepatic microcirculation.
- Conditions
- Liver Cirrhosis, Portal Hypertension
- Being tested
- research on interactions between portal hypertension and microparticles
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
research on interactions between portal hypertension and microparticlesOther
| Study group | Role | What they receive |
|---|---|---|
| cirrhotic patients | Other | We prospectively included 90 cirrhotic patients . Receives: Other: research on interactions between portal hypertension and microparticles |
| healthy volunteers | Other | The pilot cohort was compared with 10 healthy volunteers. Receives: Other: research on interactions between portal hypertension and microparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of expression of microparticles in cirrhotic patients with hepatic function of varying severity (Child- Pugh A to C) and in 10 healthy controls.
Measured: one year
Procoagulant activity of microparticles in cirrhotic patients with hepatic function of varying severity (Child- Pugh A to C) and in 10 healthy controls.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859610
- Sponsor's protocol ID
- 2013-A01258-37
- Acronym
- MicroCir
- Status last verified
- Jul 2016
- First submitted
- 28 Jul 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Microparticles in Cirrhosis and Portal Hypertension With Implications
- ClinicalTrials.gov ID
- NCT02859610
- Acronym / sponsor ID
- MicroCir / 2013-A01258-37
- Conditions
- Liver Cirrhosis, Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 9 Aug 2016 (estimated)
- 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.
research on interactions between portal hypertension and microparticles
Detailed description
It has already been shown that increased certain markers of stress, such as prolonged elevation of CRP in the absence of bacterial infection, increased free cortisol and serum copeptin, are associated with an excess of mortality in cirrhosis.
MPs are membrane vesicles of variable size between 0.1 and 1 .mu.m, released into the extracellular space following activation or cellular apoptosis. MPs are also found in the circulating blood of healthy volunteers and their plasma levels rise in certain diseases to increased thrombotic risk, such as in cancer. Their membrane is composed of antigens whose organization is characteristic of the parent cell and negatively charged phospholipids, phosphatidylserines, conferring pro-coagulant properties to these MPs.
Currently, work on the MPs are increasing following the discovery of their involvement in physiological processes such as proliferation, differentiation, cell activation and immune response but it is certainly their pro-thrombogenic power that was the most studied.
Recent studies have also implicated MPs in the pathophysiology of chronic liver disease. Cirrhotic patients have elevated concentrations of MPs from leukocytes, endothelial cells and hepatocytes compared to control subjects, and concentrations of MPs increase with worsening liver function. Increasing MPs during the cirrhosis may be related on the one hand with a decreased clearance and secondly with an excess of proinflammatory cytokines by increasing the phenomenon of intestinal bacterial translocation. The assumption of the role of systemic inflammation in the training of MPs is reinforced by the existence of a significant correlation between the original MPs hepatocyte or buffy endothelial and CRP Thus, the increase in MPs observed with the increase of PH could increase the risk of thrombosis in intestinal microcirculation leading to enterocytic suffering from ischemic, reflected by an increase in serum concentrations of I-FABP ( intestinal fatty acid binding protein). This suffering enterocytes leads to increased intestinal bacterial translocation and ultimately to increased formation of MPs. These MPs could also worsen liver function by the same phenomenon of thrombosis in the hepatic microcirculation.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cirrhotic patients | Other | Other: research on interactions between portal hypertension and microparticlesWe prospectively included 90 cirrhotic patients . |
| healthy volunteers | Other | Other: research on interactions between portal hypertension and microparticlesThe pilot cohort was compared with 10 healthy volunteers. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Non infected cirrhotic patient (30 patients Child-Pugh A, 30 Child-Pugh B et 30 Child-Pugh C).
- 10 heathly volunteer (groupe contrôle).
Key exclusion criteria (12 listed)
- legal incapacity or limited legal capacity
- Subject unlikely to cooperate in the study and / or low early cooperation by the investigator
- Subject without health insurance
- Pregnant woman
- About being in the disqualification of another study or under the "national register of volunteers."
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 |
|---|---|---|
| research on interactions between portal hypertension and microparticles | Other | cirrhotic patients, healthy volunteers |
Primary outcome
Level of expression of microparticles in cirrhotic patients with hepatic function of varying severity (Child- Pugh A to C) and in 10 healthy controls.
Time frame: one year
Procoagulant activity of microparticles in cirrhotic patients with hepatic function of varying severity (Child- Pugh A to C) and in 10 healthy controls.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing research on interactions between portal hypertension and microparticles in people with Liver Cirrhosis and Portal Hypertension, run by Centre Hospitalier Universitaire de Besancon.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of expression of microparticles in cirrhotic patients with hepatic function of varying severity (Child- Pugh A to C) and in 10 healthy controls. (time frame: one year). The study lists 2 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 9 Aug 2016.