Survey of Non-Variceal Upper Gastro Intestinal Bleeding in Vietnamese Patients

Re-bleeding in NVUGIB Clinical Trial

— NIS-PUB  

Official title:

Survey of Non-Variceal Upper Gastro Intestinal Bleeding in Vietnamese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292915
• Other study ID #: NIS-GVN-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: February 9, 2011
• Last updated: May 15, 2014
• Start date: October 2011
• Est. completion date: January 2013

Study information

• Verified date: May 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Heath
• Study type: Observational

Clinical Trial Summary

The main aim of the study is to describes the outcomes of patients with Upper Gastrointestinal Bleed (UGIB) in a real-life setting. Additionally analyse assessed predictors of outcome, including the impact of hemostatic endoscopic and pharmacologic therapies.

Description:

MSD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1044
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (>=18yrs) admitted to the hospital, or inpatients admitted for another reason, presenting with overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia...

• Evidence that an upper GI endoscopy was performed

Exclusion Criteria:

• GI bleeding not from NVUGIB

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Re-bleeding in NVUGIB

Locations

Country	Name	City	State
Vietnam	Research Site	Danang
Vietnam	Research Site	Hanoi
Vietnam	Research Site	HoChiMinh City

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rebleeding (within 7 days from the Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB) episode)		7 days	No
Secondary	Surgery due to re-bleeding		7 days	No
Secondary	Mortality due to bleeding		7 days	No
Secondary	Rebleeding in high risk peptic ulcer patients		7 days	No

External Links

•   CSR_Synopsis_NIS-GVN-DUM-2010_1