Transient Elastography and Variceal Bleeding | NCT00635687

Studies
Transient Elastography and Variceal Bleeding

NCT00635687

Sponsor

University Hospital, Rouen

Status

Terminated

Last Update Posted

Mar 5, 2013Estimated

Enrollment

29Actual

Phase

Not Applicable

Conditions

Bleeding

Interventions

Fibroscan

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of recruitment

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Mar 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Mar 7, 2008

First Submission Date that Met QC Criteria

Mar 13, 2008

First Posted Date

Mar 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2013

Last Update Posted Date

Mar 5, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fibroscan	Experimental		Device: Fibroscan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fibroscan	Device	transient elastography measure - Liver stiffness	Fibroscan

Measure	Description	Time Frame
Bleeding recurrence rate		J45 post first hemorrage

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sophie HERVE, MD	University Hospital, Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UH Amiens		Amiens		80054	France
UH Caen

Condition Browse Module

MeSH Terms

ID	Term
D006470	Hemorrhage

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided