- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00164905
Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage
August 27, 2012 updated by: James Yun-wong Lau, Chinese University of Hong Kong
Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage: Can it Guide the Use of and Predict Failure of Endoscopic Treatment? A Prospective, Multicenter, Randomized, Controlled Study
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
121
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hong Kong SAR, China
- Endoscopy Center, Prince of Wales Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- SBP ≤ 90mmHg; P of ≥110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or,
- Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or,
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Doppler ultrasound
|
Applying to ulcer base to assess the blood flow underneath the ulcer
Other Names:
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No Intervention: No Doppler ultrasound
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrent bleeding
Time Frame: Within 30 days
|
Within 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Length of stay
Time Frame: Within 56 days
|
Within 56 days
|
ICU utilization
Time Frame: Within 56 days
|
Within 56 days
|
Blood Transfusion during hospital
Time Frame: Within 56 days
|
Within 56 days
|
Need for urgent/emergent ulcer surgery for bleeding
Time Frame: Within 56 days
|
Within 56 days
|
Need for angiographic treatment of bleeding
Time Frame: Within 56 days
|
Within 56 days
|
Death
Time Frame: within 56 days
|
within 56 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
August 28, 2012
Last Update Submitted That Met QC Criteria
August 27, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DOP-US study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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