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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01292915
First Posted: February 10, 2011
Last Update Posted: May 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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:


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 ]

Secondary Outcome Measures:
  • Surgery due to re-bleeding [ Time Frame: 7 days ]
  • Mortality due to bleeding [ Time Frame: 7 days ]
  • Rebleeding in high risk peptic ulcer patients [ Time Frame: 7 days ]

Enrollment: 1044
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Detailed Description:
MSD
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292915


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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01292915     History of Changes
Other Study ID Numbers: NIS-GVN-DUM-2010/1
First Submitted: February 9, 2011
First Posted: February 10, 2011
Last Update Posted: May 16, 2014
Last Verified: May 2014

Keywords provided by AstraZeneca:
Re-bleeding, NVUGIB

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