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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01292915
First received: February 9, 2011
Last updated: May 15, 2014
Last verified: May 2014
  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 ] [ 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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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: May 15, 2014
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 August 28, 2014