search
Back to results

Transient Elastography and Variceal Bleeding (PROME)

Primary Purpose

Bleeding

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fibroscan
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bleeding focused on measuring variceal bleeding, transient elastography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • UH Amiens
  • UH Caen
  • UH Lille
  • Rouen University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fibroscan

Arm Description

Outcomes

Primary Outcome Measures

Bleeding recurrence rate

Secondary Outcome Measures

Full Information

First Posted
March 7, 2008
Last Updated
March 4, 2013
Sponsor
University Hospital, Rouen
search

1. Study Identification

Unique Protocol Identification Number
NCT00635687
Brief Title
Transient Elastography and Variceal Bleeding
Acronym
PROME
Official Title
Can Liver Stiffness Values Predict Early Rebleeding in Variceal Rupture
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding
Keywords
variceal bleeding, transient elastography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibroscan
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fibroscan
Intervention Description
transient elastography measure - Liver stiffness
Primary Outcome Measure Information:
Title
Bleeding recurrence rate
Time Frame
J45 post first hemorrage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie HERVE, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
UH Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
UH Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

Learn more about this trial

Transient Elastography and Variceal Bleeding

We'll reach out to this number within 24 hrs