BleedingPROMENCT00635687
Transient Elastography and Variceal Bleeding
A study testing Fibroscan in people with Bleeding, run by University Hospital, Rouen at 4 sites in France.
Trial summary
Transient elastography is a new non-invasive rapid and reproducible method, allowing evaluating liver fibrosis by measurement of liver stiffness. The aim of our study is to evaluate if the liver stiffness can predict the recurrence of upper variceal bleeding in cirrhotic patients hospitalized for variceal rupture. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bleeding
- What is being tested?
- Fibroscan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesFrance
- Study dates
- Mar 2008to May 2012
- 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
- Informed consent form signed
- Social security affiliation
- Variceal bleeding with hematemesis or melena within 24 hours of inclusion
- Age > 18 years
- Scheduled to undergo endoscopy within 24 hours of hospital admission
Who cannot join
- Hepatocarcinoma
- Upper Gastro Intestinal bleeding for other causes than variceal bleeding
- Concomitant disease with a life expectancy of less than 45 days
- Rebleeding within 24 hours after first endoscopy
- Technical failure of transient elastography
Trial locations and contacts
4 sites in 1 country.
France4 sites
UH Amiens
Amiens, 80054
UH Caen
Caen, 14033
UH Lille
Lille, 59000
Rouen University Hospital
Rouen, 76031
About this study
Official title: Can Liver Stiffness Values Predict Early Rebleeding in Variceal Rupture
Transient elastography is a new non-invasive rapid and reproducible method, allowing evaluating liver fibrosis by measurement of liver stiffness.
The aim of our study is to evaluate if the liver stiffness can predict the recurrence of upper variceal bleeding in cirrhotic patients hospitalized for variceal rupture.
- Conditions
- Bleeding
- Being tested
- Fibroscan
- Keywords
- variceal bleeding, transient elastography
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanDevice
transient elastography measure - Liver stiffness
| Study group | Role | What they receive |
|---|---|---|
| Fibroscan | Experimental | Not described Receives: Device: Fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding recurrence rate
Measured: J45 post first hemorrage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2012
- Study completionMay 2012
Why it stopped: lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie HERVE, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635687
- Sponsor's protocol ID
- 2006/102/HP
- Acronym
- PROME
- Status last verified
- Mar 2013
- First submitted
- 7 Mar 2008
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Liver Stiffness Values Predict Early Rebleeding in Variceal Rupture
- ClinicalTrials.gov ID
- NCT00635687
- Acronym / sponsor ID
- PROME / 2006/102/HP
- Conditions
- Bleeding
- Keywords
- variceal bleeding, transient elastography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of recruitment
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Mar 2008 (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.
Transient elastography is a new non-invasive rapid and reproducible method, allowing evaluating liver fibrosis by measurement of liver stiffness.
The aim of our study is to evaluate if the liver stiffness can predict the recurrence of upper variceal bleeding in cirrhotic patients hospitalized for variceal rupture.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibroscan | Experimental | Device: Fibroscan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent form signed
- Social security affiliation
- Variceal bleeding with hematemesis or melena within 24 hours of inclusion
- Age > 18 years
- Scheduled to undergo endoscopy within 24 hours of hospital admission
Key exclusion criteria (5 listed)
- Hepatocarcinoma
- Upper Gastro Intestinal bleeding for other causes than variceal bleeding
- Concomitant disease with a life expectancy of less than 45 days
- Rebleeding within 24 hours after first endoscopy
- Technical failure of transient elastography
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 |
|---|---|---|
| Fibroscantransient elastography measure - Liver stiffness | Device | Fibroscan |
Primary outcome
Bleeding recurrence rate
Time frame: J45 post first hemorrage
Results and safety
The study was stopped early (reason given: lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
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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.
Sophie HERVE, MD principal investigator
University Hospital, Rouen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibroscan in people with Bleeding, run by University Hospital, Rouen at 4 sites 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 5 inclusion and 5 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 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was stopped early (reason given: lack of recruitment). 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?
Bleeding recurrence rate (time frame: J45 post first hemorrage). 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 5 Mar 2013.