Status:
TERMINATED
Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
University Hospitals Cleveland Medical Center
Conditions:
Peptic Ulcer Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
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 the...
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 en...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00164905
Start Date
September 1 2004
End Date
August 1 2010
Last Update
August 28 2012
Active Locations (1)
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1
Endoscopy Center, Prince of Wales Hospital
Hong Kong SAR, China