Microparticles in Cirrhosis and Portal Hypertension
MicroCir
Characterization of Microparticles in Cirrhosis and Portal Hypertension With Implications
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
research on interactions between portal hypertension and microparticles
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 9, 2016
CompletedAugust 9, 2016
July 1, 2016
1 year
July 28, 2016
August 4, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Level of expression of microparticles in cirrhotic patients with hepatic function of varying severity (Child- Pugh A to C) and in 10 healthy controls.
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.
one year
Study Arms (2)
cirrhotic patients
OTHERWe prospectively included 90 cirrhotic patients .
healthy volunteers
OTHERThe pilot cohort was compared with 10 healthy volunteers.
Interventions
Eligibility Criteria
You may qualify if:
- Non infected cirrhotic patient (30 patients Child-Pugh A, 30 Child-Pugh B et 30 Child-Pugh C).
- heathly volunteer (groupe contrôle).
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 9, 2016
Study Start
January 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
August 9, 2016
Record last verified: 2016-07