CirrhosisNCT00188097
Diagnosis of Variceal Bleeding and Its Control in Cirrhosis
A study of Cirrhosis, run by University Hospital, Angers.
Trial summary
The aim of the study was to determine the independent predictors of variceal bleeding and control of bleeding in cirrhosis as no scientific assessment have been perfomed until now Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Nov 1999to Jun 2002
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patients admitted for an acute complication of cirrhosis
- admission ≤ 6 hours of inclusion
Who cannot join
- Child-Pugh score > 13
- Digestive hemorrhage
- Non cirrhotic portal hypertension
About this study
The aim of the study was to determine the independent predictors of variceal bleeding and control of bleeding in cirrhosis as no scientific assessment have been perfomed until now
- Conditions
- Cirrhosis
- Being tested
- Diagnosis of variceal bleeding and dits control in cirrhosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of variceal bleeding and dits control in cirrhosisBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
variceal bleeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 1999
- Study completionJun 2002
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, AngersThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Paul Cales, PHD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188097
- Sponsor's protocol ID
- PHRC 03-04
- Status last verified
- Aug 2005
- First submitted
- 12 Sep 2005
- Last updated
- 19 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Variceal Bleeding and Its Control in Cirrhosis
- ClinicalTrials.gov ID
- NCT00188097
- Acronym / sponsor ID
- PHRC 03-04
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 400 participants
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Nov 1999
- Study completion
- Jun 2002
- First posted
- 16 Sep 2005 (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.
The aim of the study was to determine the independent predictors of variceal bleeding and control of bleeding in cirrhosis as no scientific assessment have been perfomed until now
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cirrhotic patients admitted for an acute complication of cirrhosis
- admission ≤ 6 hours of inclusion
Key exclusion criteria (3 listed)
- Child-Pugh score > 13
- Digestive hemorrhage
- Non cirrhotic portal hypertension
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 |
|---|---|---|
| Diagnosis of variceal bleeding and dits control in cirrhosis | Behavioural | – |
Primary outcome
variceal bleeding
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2006.
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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.
Paul Cales, PHD principal investigator
UH Angers
Questions about this trial
What is this clinical trial studying?
A study of Cirrhosis, run by University Hospital, Angers.
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 3 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: stopped early, as of the sponsor's last update on 19 Jan 2006. 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 was stopped early. Results are not available in the source record.
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?
variceal bleeding. 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 19 Jan 2006.