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

Gastrointestinal Hemorrhage Clinical Trial

— ENERGIB  

Official title:

European Survey of Non-Variceal Upper Gastro Intestinal Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797641
• Other study ID #: NIS-GEU-DUM-2008/2
• Status: Completed
• Phase: N/A
• First received: November 21, 2008
• Last updated: December 3, 2009
• Start date: January 2009
• Est. completion date: March 2009

Study information

• Verified date: December 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeBelgium: Ethics CommitteeGreece: National Organization of MedicinesGreece: Ethics CommitteeItaly: Ethics CommitteeTurkey: Ethics CommitteeNorway:National Committee for Medical and Health Research EthicsNorway: Data Protection AuthorityPortugal: Health Ethic CommitteePortugal: National Pharmacy and Medicines Institute
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Gastrointestinal Ulcer
• Hemorrhage
• Non-variceal Upper Gastrointestinal Bleeding

Locations

Country	Name	City	State
Belgium	Research site	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
Greece	Research site	Athens
Greece	Research site	Larissa
Greece	Research site	Thessaloniki
Italy	Research site	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
Norway	Research site	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
Portugal	Research site	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
Spain	Research site	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
Turkey	Research site	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Greece,  Italy,  Norway,  Portugal,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	To describe clinical management and how this compares across countries and Hospital types		Up to 30 days after the episode (bleeding)	No
Secondary	To assess predictive factors for clinical management strategies and predictive factors related to clinical outcomes		Up to 30 days after the episode (bleeding)	No
Secondary	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)	No