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

December 3, 2009 updated by: AstraZeneca

European Survey of Non-Variceal Upper Gastro Intestinal Bleeding

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • Research Site
      • Anderlecht, Belgium
        • Research Site
      • Assebroek, Belgium
        • Research Site
      • Braine L'alleud, Belgium
        • Research Site
      • Brasschaat, Belgium
        • Research Site
      • Brugge, Belgium
        • Research Site
      • Bruxelles, Belgium
        • Research Site
      • Charleroi, Belgium
        • Research Site
      • Deurne, Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Gent, Belgium
        • Research Site
      • Geraardsbergen, Belgium
        • Research Site
      • Hasselt, Belgium
        • Research Site
      • Herentals, Belgium
        • Research Site
      • Kortrijk, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
      • Lier, Belgium
        • Research Site
      • Mechelen, Belgium
        • Research Site
      • Ottignies Lln, Belgium
        • Research Site
      • Tielt, Belgium
        • Research Site
      • Tournai, Belgium
        • Research Site
      • Turnhout, Belgium
        • Research Site
      • Wetteren, Belgium
        • Research Site
      • Wilrijk, Belgium
        • Research Site
      • Zottegem, Belgium
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Larissa, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • Italy
      • Bolzano, Italy
        • Research Site
      • Cosenza, Italy
        • Research Site
      • Crema, Italy
        • Research Site
      • Forli, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Novara, Italy
        • Research Site
      • Revenna, Italy
        • Research Site
      • Roma, Italy
        • Research Site
      • S. Giovanni Rotondo, Italy
        • Research Site
      • Siena, Italy
        • Research Site
      • Trieste, Italy
        • Research Site
  • Norway
      • Alesund, Norway
        • Research Site
      • Arendel, Norway
        • Research Site
      • Bodo, Norway
        • Research Site
      • Drammen, Norway
        • Research Site
      • Fredrikstad, Norway
        • Research Site
      • Kristiansand, Norway
        • Research Site
      • Levanger, Norway
        • Research Site
      • Lillehammer, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Rud, Norway
        • Research Site
      • Stavanger, Norway
        • Research Site
      • Tonsberg, Norway
        • Research Site
      • Tromso, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
  • Portugal
      • Almada, Portugal
        • Research Site
      • Angra Do Heroismo, Portugal
        • Research Site
      • Braga, Portugal
        • Research Site
      • Caldas Da Rainha, Portugal
        • Research Site
      • Castelo Branco, Portugal
        • Research Site
      • Covilha, Portugal
        • Research Site
      • Funchal, Portugal
        • Research Site
      • Leiria, Portugal
        • Research Site
      • Ponta Delgada, Portugal
        • Research Site
      • Santarem, Portugal
        • Research Site
      • Torres Novas, Portugal
        • Research Site
  • Spain
      • Alcazar de San Juan, Spain
        • Research Site
      • Alicante, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Burgos, Spain
        • Research Site
      • Cordoba, Spain
        • Research Site
      • Huesca, Spain
        • Research Site
      • La Cuesta de Arguijon, Spain
        • Research Site
      • Las Palmas de Gran Canaria, Spain
        • Research Site
      • Logrono, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Marbella, Spain
        • Research Site
      • Murcia, Spain
        • Research Site
      • Orense, Spain
        • Research Site
      • Oviedo, Spain
        • Research Site
      • Pamplona, Spain
        • Research Site
      • Sabadell, Spain
        • Research Site
      • Santiago de Compostela, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
      • Valencia, Spain
        • Research Site
      • Zaragoza, Spain
        • Research Site
  • Turkey
      • Ankara, Turkey
        • Research Site
      • Antalya, Turkey
        • Research Site
      • Batman, Turkey
        • Research Site
      • Bursa, Turkey
        • Research Site
      • Diyarbakir, Turkey
        • Research Site
      • Elazig, Turkey
        • Research Site
      • Gaziantep, Turkey
        • Research Site
      • Istambul, Turkey
        • Research Site
      • Izmir, Turkey
        • Research Site
      • Konya, Turkey
        • Research Site
      • Malatya, Turkey
        • Research Site
      • Mersin, Turkey
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Up to 30 days after the episode (bleeding)

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe clinical management and how this compares across countries and Hospital types
Time Frame: Up to 30 days after the episode (bleeding)
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)
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)
Up to 30 days after the episode (bleeding)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Ángel Lanas, MD, Hospital Clínico Universitario Lozano Blesa, Zaragoza (Spain)
  • Study Director: Javier N Rivero, MSc, Medical Department, AstraZeneca Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

November 21, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Estimate)

December 4, 2009

Last Update Submitted That Met QC Criteria

December 3, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-GEU-DUM-2008/2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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