Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT00164905
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00164905
Study Brief:
Protocol Section:
NCT00164905