Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage | NCT00164905

Studies
Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

NCT00164905

Sponsor

Chinese University of Hong Kong

Status

Terminated

Last Update Posted

Aug 28, 2012Estimated

Enrollment

121Actual

Phase

Not Applicable

Conditions

Peptic Ulcer Hemorrhage

Interventions

Doppler ultrasound probe

Countries

China

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

Aug 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Aug 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 14, 2005Estimated

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

Aug 27, 2012

Last Update Posted Date

Aug 28, 2012Estimated

Name	Class
University Hospitals Cleveland Medical Center	OTHER

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

The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail endoscopic therapy.

Detailed Description

Bleeding peptic ulcer is a life-threatening emergency. Endoscopic therapy is a proven technique in the acute hemostasis of bleeding ulcers. Currently there is no objective assessment of adequacy of endoscopic therapy. Endoscopic Doppler ultrasound enables endoscopists in detecting blood flow in a vessel beneath an ulcer. A persistent signal after endoscopic therapy predicts recurrent bleeding. The current study proposes to compare assessment of ulcer base using either Doppler ultrasound or endoscopists' interpretation of ulcer floors. The trial design is one of a prospective randomized controlled cross-over study in which patients with severe upper gastrointestinal bleeding and documented peptic ulcers at endoscopy are enrolled.

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

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Doppler ultrasound	Active Comparator		Device: Doppler ultrasound probe
No Doppler ultrasound	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doppler ultrasound probe	Device	Applying to ulcer base to assess the blood flow underneath the ulcer	Doppler ultrasound

Measure	Description	Time Frame
Recurrent bleeding		Within 30 days

Measure	Description	Time Frame
Length of stay		Within 56 days
ICU utilization		Within 56 days
Blood Transfusion during hospital

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clean base ulcer with severe upper GIB (defined as melaena, hematochezia, hematemesis, and/or gross blood in NG lavage), and any one of the following:
1. SBP ≤ 90mmHg; P of ≥110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or,
2. Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or,
3. A documented HCT drop of at lest 6% from baseline.
Endoscopically confirmed bleeding from GU, DU, pyloric ulcer, or anastomotic ulcer
Pt can either have primary or secondary acute UGI haemorrhage

Exclusion Criteria:

Bleeding site from lesion other than GU, DU, pyloric or anastomotic ulcer
there is more than one type of significant bleeding lesion
Documented hx of cirrhosis / portal HT
ESRF requiring any form of dialysis
Expected or persistent (>24hrs) coagulopathy with INR> 1.5
Platelet count is under 50000/mm3
Aspirin User / Plavix [Clopidogrel] User
If the ulcer is neoplastic
Cannot obtained consent
Age < 18 or is pregnant
Severe comorbid of which life expectancy <30 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
James Y Lau, MD	Prince of Wales Hospital	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D010438	Peptic Ulcer Hemorrhage

Ancestor Terms

ID	Term
D006471	Gastrointestinal Hemorrhage
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage

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Browse Branches

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