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Survey of Non-Variceal Upper Gastro Intestinal Bleeding in Vietnamese Patients (NIS-PUB)

This study is currently recruiting participants.
Verified December 2011 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01292915
First received: February 9, 2011
Last updated: December 5, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition
Re-bleeding in NVUGIB

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Survey of Non-Variceal Upper Gastro Intestinal Bleeding in Vietnamese Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Rebleeding (within 7 days from the Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB) episode) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgery due to re-bleeding [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Mortality due to bleeding [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Rebleeding in high risk peptic ulcer patients [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1050
Study Start Date: October 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

Detailed Description:

MSD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

NVUGIB patients in 13 hospitals in Hanoi, HCMC, Danang

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292915

Contacts
Contact: AstraZeneca Vietnam Clinical Study Information +848 38278088 mailto:thithanhhuong.phan@astrazeneca.com

Locations
Vietnam
Research Site Recruiting
Danang, Vietnam
Research Site Recruiting
Hanoi, Vietnam
Research Site Recruiting
HoChiMinh City, Vietnam
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dao Van Long, MD,PhD Hanoi Medical University Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01292915     History of Changes
Other Study ID Numbers: NIS-GVN-DUM-2010/1
Study First Received: February 9, 2011
Last Updated: December 5, 2011
Health Authority: Vietnam: Ministry of Heath

Keywords provided by AstraZeneca:
Re-bleeding, NVUGIB

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013