European Survey of Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB)
ENERGIB
1 other identifier
observational
2,500
7 countries
97
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2009
Shorter than P25 for all trials
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2008
CompletedFirst Posted
Study publicly available on registry
November 25, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedDecember 4, 2009
December 1, 2009
1 month
November 21, 2008
December 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 30 days after the episode (bleeding)
Secondary Outcomes (3)
To describe clinical management and how this compares across countries and Hospital types
Up to 30 days after the episode (bleeding)
To assess predictive factors for clinical management strategies and predictive factors related to clinical outcomes
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
Up to 30 days after the episode (bleeding)
Study Arms (1)
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 Criteria
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
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (97)
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Aalst, Belgium
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Anderlecht, Belgium
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Assebroek, Belgium
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Braine-l'Alleud, Belgium
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Brasschaat, Belgium
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Bruges, Belgium
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Brussels, Belgium
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Charleroi, Belgium
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Deurne, Belgium
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Edegem, Belgium
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Geraardsbergen, Belgium
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Ghent, Belgium
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Hasselt, Belgium
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Herentals, Belgium
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Kortrijk, Belgium
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Lier, Belgium
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Liège, Belgium
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Mechelen, Belgium
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Ottignies Lln, Belgium
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Tielt, Belgium
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Tournai, Belgium
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Turnhout, Belgium
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Wetteren, Belgium
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Wilrijk, Belgium
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Zottegem, Belgium
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Athens, Greece
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Larissa, Greece
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Thessaloniki, Greece
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Bolzano, Italy
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Cosenza, Italy
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Crema, Italy
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Forlì, Italy
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Milan, Italy
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Napoli, Italy
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Novara, Italy
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Revenna, Italy
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Roma, Italy
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S. Giovanni Rotondo, Italy
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Siena, Italy
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Trieste, Italy
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Arendel, Norway
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Ålesund, Norway
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Bodø, Norway
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Drammen, Norway
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Fredrikstad, Norway
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Kristiansand, Norway
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Levanger, Norway
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Lillehammer, Norway
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Oslo, Norway
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Rud, Norway
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Stavanger, Norway
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Tromsø, Norway
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Trondheim, Norway
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Tønsberg, Norway
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Almada, Portugal
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Angra do Heroísmo, Portugal
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Braga, Portugal
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Caldas da Rainha, Portugal
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Castelo Branco, Portugal
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Covilha, Portugal
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Funchal, Portugal
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Leiria, Portugal
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Ponta Delgada, Portugal
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Santarém, Portugal
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Torres Novas, Portugal
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Alcázar de San Juan, Spain
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Alicante, Spain
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Barcelona, Spain
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Burgos, Spain
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Córdoba, Spain
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Huesca, Spain
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La Cuesta de Arguijon, Spain
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Las Palmas de Gran Canaria, Spain
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Logroño, Spain
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Madrid, Spain
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Marbella, Spain
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Murcia, Spain
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Ourense, Spain
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Oviedo, Spain
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Pamplona, Spain
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Sabadell, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Valencia, Spain
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Zaragoza, Spain
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Ankara, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Batman, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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Elâzığ, Turkey (Türkiye)
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Gaziantep, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Konya, Turkey (Türkiye)
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Malatya, Turkey (Türkiye)
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Mersin, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 23225523DERIVEDMungan 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. doi: 10.4318/tjg.2012.0402.
PMID: 23161291DERIVEDLanas 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.
PMID: 21480935DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ángel Lanas, MD
Hospital Clínico Universitario Lozano Blesa, Zaragoza (Spain)
- STUDY DIRECTOR
Javier N Rivero, MSc
Medical Department, AstraZeneca Spain
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 21, 2008
First Posted
November 25, 2008
Study Start
January 1, 2009
Primary Completion
February 1, 2009
Study Completion
March 1, 2009
Last Updated
December 4, 2009
Record last verified: 2009-12