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

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ClinicalTrials.gov Identifier: NCT00797641

Recruitment Status : Completed

First Posted : November 25, 2008

Last Update Posted : December 4, 2009

Sponsor:

Information provided by:

AstraZeneca

Study Description

Brief Summary:

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 or disease
Non-variceal Upper Gastrointestinal Bleeding Gastrointestinal Ulcer Gastrointestinal Hemorrhage

Study Design


Study Type :	Observational
Estimated Enrollment :	2500 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	European Survey of Non-Variceal Upper Gastro Intestinal Bleeding
Study Start Date :	January 2009
Actual Primary Completion Date :	February 2009
Actual Study Completion Date :	March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Gastrointestinal Bleeding

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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

Outcome Measures

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) ]

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) ]
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) ]
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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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:

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lanas A, Aabakken L, Fonseca J, Mungan Z, Papatheodoridis G, Piessevaux H, Rotondano G, Nuevo J, Tafalla M. Variability in the management of nonvariceal upper gastrointestinal bleeding in Europe: an observational study. Adv Ther. 2012 Dec;29(12):1026-36. doi: 10.1007/s12325-012-0069-x. Epub 2012 Dec 6.

Mungan Z. An observational European study on clinical outcomes associated with current management strategies for non-variceal upper gastrointestinal bleeding (ENERGIB-Turkey). Turk J Gastroenterol. 2012;23(5):463-77.

Lanas A, Aabakken L, Fonseca J, Mungan ZA, Papatheodoridis GV, Piessevaux H, Cipolletta L, Nuevo J, Tafalla M. Clinical predictors of poor outcomes among patients with nonvariceal upper gastrointestinal bleeding in Europe. Aliment Pharmacol Ther. 2011 Jun;33(11):1225-33. doi: 10.1111/j.1365-2036.2011.04651.x. Epub 2011 Apr 11.


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
First Posted:	November 25, 2008 Key Record Dates
Last Update Posted:	December 4, 2009
Last Verified:	December 2009

Keywords provided by AstraZeneca:


bleeding ulcer hemorrhage gastrointestinal diseases	digestive system disease peptic ulcer proton pump inhibitor

Additional relevant MeSH terms:


Hemorrhage Gastrointestinal Hemorrhage Pathologic Processes Gastrointestinal Diseases Digestive System Diseases

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