Non-variceal Upper Gastrointestinal BleedingENERGIBNCT00797641
European Survey of Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB)
An observational study of Non-variceal Upper Gastrointestinal Bleeding and Gastrointestinal Ulcer, run by AstraZeneca at 97 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-variceal Upper Gastrointestinal Bleeding, Gastrointestinal Ulcer, Gastrointestinal Hemorrhage
- How many people
- 2,500 participants
- Where
- 97 sitesin 7 countries
- Study dates
- Jan 2009to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- NA
Trial locations and contacts
97 sites in 7 countries.
97 sites in 7 countries
Belgium25 sites
Research site
Aalst
Research site
Anderlecht
Research site
Assebroek
Research site
Braine-l'Alleud
Research site
Brasschaat
Research site
Bruges
Research site
Brussels
Research site
Charleroi
Research site
Deurne
Research site
Edegem
Research site
Geraardsbergen
Research site
Ghent
Research site
Hasselt
Research site
Herentals
Research site
Kortrijk
Research site
Liège
Research site
Lier
Research site
Mechelen
Research site
Ottignies Lln
Research site
Tielt
Research site
Tournai
Research site
Turnhout
Research site
Wetteren
Research site
Wilrijk
Research site
Zottegem
Spain20 sites
Research site
Alcázar de San Juan
Research site
Alicante
Research site
Barcelona
Research site
Burgos
Research site
Córdoba
Research site
Huesca
Research site
La Cuesta de Arguijon
Research site
Las Palmas de Gran Canaria
Research site
Logroño
Research site
Madrid
Research site
Marbella
Research site
Murcia
Research site
Ourense
Research site
Oviedo
Research site
Pamplona
Research site
Sabadell
Research site
Santiago de Compostela
Research site
Seville
Research site
Valencia
Research site
Zaragoza
Norway14 sites
Research site
Ålesund
Research site
Arendel
Research site
Bodø
Research site
Drammen
Research site
Fredrikstad
Research site
Kristiansand
Research site
Levanger
Research site
Lillehammer
Research site
Oslo
Research site
Rud
Research site
Stavanger
Research site
Tønsberg
Research site
Tromsø
Research site
Trondheim
Italy12 sites
Research site
Bolzano
Research site
Cosenza
Research site
Crema
Research site
Forlì
Research site
Milan
Research site
Naples
Research site
Novara
Research site
Revenna
Research site
Roma
Research site
S. Giovanni Rotondo
Research site
Siena
Research site
Trieste
Turkey (Türkiye)12 sites
Research site
Ankara
Research site
Antalya
Research site
Batman
Research site
Bursa
Research site
Diyarbakır
Research site
Elâzığ
Research site
Gaziantep
Research site
Istanbul
Research site
Izmir
Research site
Konya
Research site
Malatya
Research site
Mersin
Portugal11 sites
Research site
Almada
Research site
Angra do Heroísmo
Research site
Braga
Research site
Caldas da Rainha
Research site
Castelo Branco
Research site
Covilha
Research site
Funchal
Research site
Leiria
Research site
Ponta Delgada
Research site
Santarém
Research site
Torres Novas
Greece3 sites
Research site
Athens
Research site
Larissa
Research site
Thessaloniki
About this study
Official title: 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.
- Conditions
- Non-variceal Upper Gastrointestinal Bleeding, Gastrointestinal Ulcer, Gastrointestinal Hemorrhage
- Keywords
- bleeding, ulcer, hemorrhage, gastrointestinal diseases, digestive system disease, peptic ulcer, proton pump inhibitor
- Medical subject headings
- Gastrointestinal Hemorrhage, Hemorrhage, Ulcer, Gastrointestinal Diseases, Digestive System Diseases, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 30 days after the episode (bleeding)
Secondary outcomes (3)
To describe clinical management and how this compares across countries and Hospital types
Measured: Up to 30 days after the episode (bleeding)
To assess predictive factors for clinical management strategies and predictive factors related to clinical outcomes
Measured: 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
Measured: Up to 30 days after the episode (bleeding)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-variceal Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ángel Lanas, MD, Principal investigator, Hospital Clínico Universitario Lozano Blesa, Zaragoza (Spain)Javier N Rivero, MSc, Study director, Medical Department, AstraZeneca Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797641
- Sponsor's protocol ID
- NIS-GEU-DUM-2008/2
- Acronym
- ENERGIB
- Status last verified
- Dec 2009
- First submitted
- 21 Nov 2008
- Last updated
- 4 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23225523Mungan 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.
PubMed 23161291Lanas 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.
PubMed 21480935
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Survey of Non-Variceal Upper Gastro Intestinal Bleeding
- ClinicalTrials.gov ID
- NCT00797641
- Acronym / sponsor ID
- ENERGIB / NIS-GEU-DUM-2008/2
- Conditions
- Non-variceal Upper Gastrointestinal Bleeding, Gastrointestinal Ulcer, Gastrointestinal Hemorrhage
- Keywords
- bleeding, ulcer, hemorrhage, gastrointestinal diseases, digestive system disease, peptic ulcer, proton pump inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2009.
- Derived from this study: PubMed 23225523Lanas 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.
- Derived from this study: PubMed 23161291Mungan 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.
- Derived from this study: PubMed 21480935Lanas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ángel Lanas, MD principal investigator
Hospital Clínico Universitario Lozano Blesa, Zaragoza (Spain)
Javier N Rivero, MSc study director
Medical Department, AstraZeneca Spain
97 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-variceal Upper Gastrointestinal Bleeding and Gastrointestinal Ulcer, run by AstraZeneca at 97 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in Belgium, Spain, Norway, Italy, Turkey (Türkiye) and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 30 days after the episode (bleeding)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00797641, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2009.