European Survey of Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB) (ENERGIB)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00797641
First received: November 21, 2008
Last updated: December 3, 2009
Last verified: December 2009
  Purpose

The aim of this study is to assess the current management strategies in a pan-European "real-life" setting to uncover the unmet need in this area: non-variceal gastrointestinal bleedings.


Condition
Non-variceal Upper Gastrointestinal Bleeding
Gastrointestinal Ulcer
Gastrointestinal Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: European Survey of Non-Variceal Upper Gastro Intestinal Bleeding

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To describe clinical outcomes associated with current strategies of endoscopic and pharmacological treatment in several European countries, in respect of bleeding continuation, rebleeding, surgery and in-hospital mortality [ Time Frame: Up to 30 days after the episode (bleeding) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe clinical management and how this compares across countries and Hospital types [ Time Frame: Up to 30 days after the episode (bleeding) ] [ Designated as safety issue: No ]
  • To assess predictive factors for clinical management strategies and predictive factors related to clinical outcomes [ Time Frame: Up to 30 days after the episode (bleeding) ] [ Designated as safety issue: No ]
  • To assess health care resource consumption in patients admitted with non-variceal upper gastrointestinal bleeding and the main drivers [ Time Frame: Up to 30 days after the episode (bleeding) ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients 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, as well as other clinical or laboratory evidence of acute blood loss from the upper gastrointestinal tract

  Eligibility

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

Patients 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, as well as other clinical or laboratory evidence of acute blood loss from the upper gastrointestinal tract

Criteria

Inclusion Criteria:

  • Patients admitted to the hospital or inpatients with an overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia, as well as other clinical/laboratory evidences of acute blood loss from the upper GI tract
  • Evidence that an upper GI endoscopy was performed
  • The complete medical record is available for study related hospitalization.

Exclusion Criteria:

  • NA
  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: NCT00797641

  Show 97 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Ángel Lanas, MD Hospital Clínico Universitario Lozano Blesa, Zaragoza (Spain)
Study Director: Javier N Rivero, MSc Medical Department, AstraZeneca Spain
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Rick Lones, BM MRCGP MFPM DRCOG DFFP, European Medical Affairs Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00797641     History of Changes
Other Study ID Numbers: NIS-GEU-DUM-2008/2
Study First Received: November 21, 2008
Last Updated: December 3, 2009
Health Authority: Spain: Ethics Committee
Belgium: Ethics Committee
Greece: National Organization of Medicines
Greece: Ethics Committee
Italy: Ethics Committee
Turkey: Ethics Committee
Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority
Portugal: Health Ethic Committee
Portugal: National Pharmacy and Medicines Institute

Keywords provided by AstraZeneca:
bleeding
ulcer
hemorrhage
gastrointestinal diseases
digestive system disease
peptic ulcer
proton pump inhibitor

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

ClinicalTrials.gov processed this record on October 22, 2014