Clinical trial NCT00797641: European Survey of Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB)
Official title: European Survey of Non-Variceal Upper Gastro Intestinal Bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-variceal Upper Gastrointestinal Bleeding
Gastrointestinal Ulcer
Gastrointestinal Hemorrhage
Keywords: bleeding
ulcer
hemorrhage
gastrointestinal diseases
digestive system disease
peptic ulcer
proton pump inhibitor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-25
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Up to 30 days after the episode (bleeding)
Secondary outcomes:
measure: To describe clinical management and how this compares across countries and Hospital types
timeFrame: Up to 30 days after the episode (bleeding)
measure: To assess predictive factors for clinical management strategies and predictive factors related to clinical outcomes
timeFrame: Up to 30 days after the episode (bleeding)
measure: To assess health care resource consumption in patients admitted with non-variceal upper gastrointestinal bleeding and the main drivers
timeFrame: Up to 30 days after the episode (bleeding)
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Research site
city: Anderlecht
country: Belgium
facility: Research site
city: Assebroek
country: Belgium
facility: Research site
city: Braine L'alleud
country: Belgium
facility: Research site
city: Brasschaat
country: Belgium
facility: Research site
city: Brugge
country: Belgium
facility: Research site
city: Bruxelles
country: Belgium
facility: Research site
city: Charleroi
country: Belgium
facility: Research site
city: Deurne
country: Belgium
facility: Research site
city: Edegem
country: Belgium
facility: Research site
city: Gent
country: Belgium
facility: Research site
city: Geraardsbergen
country: Belgium
facility: Research site
city: Hasselt
country: Belgium
facility: Research site
city: Herentals
country: Belgium
facility: Research site
city: Kortrijk
country: Belgium
facility: Research site
city: Liege
country: Belgium
facility: Research site
city: Lier
country: Belgium
facility: Research site
city: Mechelen
country: Belgium
facility: Research site
city: Ottignies Lln
country: Belgium
facility: Research site
city: Tielt
country: Belgium
facility: Research site
city: Tournai
country: Belgium
facility: Research site
city: Turnhout
country: Belgium
facility: Research site
city: Wetteren
country: Belgium
facility: Research site
city: Wilrijk
country: Belgium
facility: Research site
city: Zottegem
country: Belgium
facility: Research site
city: Athens
country: Greece
facility: Research site
city: Larissa
country: Greece
facility: Research site
city: Thessaloniki
country: Greece
facility: Research site
city: Bolzano
country: Italy
facility: Research site
city: Cosenza
country: Italy
facility: Research site
city: Crema
country: Italy
facility: Research site
city: Forli
country: Italy
facility: Research site
city: Milano
country: Italy
facility: Research site
city: Napoli
country: Italy
facility: Research site
city: Novara
country: Italy
facility: Research site
city: Revenna
country: Italy
facility: Research site
city: Roma
country: Italy
facility: Research site
city: S. Giovanni Rotondo
country: Italy
facility: Research site
city: Siena
country: Italy
facility: Research site
city: Trieste
country: Italy
facility: Research site
city: Alesund
country: Norway
facility: Research site
city: Arendel
country: Norway
facility: Research site
city: Bodo
country: Norway
facility: Research site
city: Drammen
country: Norway
facility: Research site
city: Fredrikstad
country: Norway
facility: Research site
city: Kristiansand
country: Norway
facility: Research site
city: Levanger
country: Norway
facility: Research site
city: Lillehammer
country: Norway
facility: Research site
city: Oslo
country: Norway
facility: Research site
city: Rud
country: Norway
facility: Research site
city: Stavanger
country: Norway
facility: Research site
city: Tonsberg
country: Norway
facility: Research site
city: Tromso
country: Norway
facility: Research site
city: Trondheim
country: Norway
facility: Research site
city: Almada
country: Portugal
facility: Research site
city: Angra Do Heroismo
country: Portugal
facility: Research site
city: Braga
country: Portugal
facility: Research site
city: Caldas Da Rainha
country: Portugal
facility: Research site
city: Castelo Branco
country: Portugal
facility: Research site
city: Covilha
country: Portugal
facility: Research site
city: Funchal
country: Portugal
facility: Research site
city: Leiria
country: Portugal
facility: Research site
city: Ponta Delgada
country: Portugal
facility: Research site
city: Santarem
country: Portugal
facility: Research site
city: Torres Novas
country: Portugal
facility: Research site
city: Alcazar de San Juan
country: Spain
facility: Research site
city: Alicante
country: Spain
facility: Research site
city: Barcelona
country: Spain
facility: Research site
city: Burgos
country: Spain
facility: Research site
city: Cordoba
country: Spain
facility: Research site
city: Huesca
country: Spain
facility: Research site
city: La Cuesta de Arguijon
country: Spain
facility: Research site
city: Las Palmas de Gran Canaria
country: Spain
facility: Research site
city: Logrono
country: Spain
facility: Research site
city: Madrid
country: Spain
facility: Research site
city: Marbella
country: Spain
facility: Research site
city: Murcia
country: Spain
facility: Research site
city: Orense
country: Spain
facility: Research site
city: Oviedo
country: Spain
facility: Research site
city: Pamplona
country: Spain
facility: Research site
city: Sabadell
country: Spain
facility: Research site
city: Santiago de Compostela
country: Spain
facility: Research site
city: Sevilla
country: Spain
facility: Research site
city: Valencia
country: Spain
facility: Research site
city: Zaragoza
country: Spain
facility: Research site
city: Ankara
country: Turkey
facility: Research site
city: Antalya
country: Turkey
facility: Research site
city: Batman
country: Turkey
facility: Research site
city: Bursa
country: Turkey
facility: Research site
city: Diyarbakir
country: Turkey
facility: Research site
city: Elazig
country: Turkey
facility: Research site
city: Gaziantep
country: Turkey
facility: Research site
city: Istambul
country: Turkey
facility: Research site
city: Izmir
country: Turkey
facility: Research site
city: Konya
country: Turkey
facility: Research site
city: Malatya
country: Turkey
facility: Research site
city: Mersin
country: Turkey
facility: Research site
Study officials:
affiliation: Hospital Clínico Universitario Lozano Blesa, Zaragoza (Spain)
name: Ángel Lanas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Department, AstraZeneca Spain
name: Javier N Rivero, MSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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. doi: 10.4318/tjg.2012.0402.
citation: 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.