Plain English Summary
Background and study aims
Upper gastrointestinal bleeding refers to bleeding in the esophagus (foodpipe), stomach or duodenum (first section of the small intestine). Recent guidelines have recommended the use of early risk assessment in patients with upper gastrointestinal bleeding. A number of risk scores have been developed for use in this situation, some of which can be calculated soon after admission to hospital and some of which require endoscopy for calculation. Endoscopy involves a flexible tube with an attached light and camera being passed through the mouth and throat, allowing the doctor to view the esophagus, stomach and duodenum. There have been several studies comparing various combinations of risk scores for upper gastrointestinal bleeding, but we do not know which is the best score for use in clinical practice. The aim of this study is to compare the usefulness of five risk scores in patients with upper gastrointestinal bleeding.
Who can participate?
Patients with upper gastrointestinal bleeding.
What does the study involve?
We collect data including patients’ characteristics, blood test results, findings at endoscopy (if undertaken), and any treatments such as blood transfusion, endoscopic treatment and surgery. Bleeding, length of hospital stay and number of deaths are also recorded. The data is then used to compare the predictive abilities of the different risk scores.
What are the possible benefits and risks of participating?
The results of this study will be used to develop a new improved score to improve the prediction of outcome for patients with upper gastrointestinal bleeding. All patient management will be as per standard of care for patients with upper gastrointestinal bleeding. All collected data will be anonymized.
Where is the study run from?
1. Glasgow Royal Infirmary, Scotland, UK
2. Yale University Hospital, USA
3. Odense University Hospital, Denmark
4. Royal Cornwall Hospital, Truro, UK
5. Singapore General Hospital
6. Dunedin Public Hospital, New Zealand
7. Humanitas Research Hospital, Milan, Italy
8. University Hospital, London, Ontario, Canada
When is the study starting and how long is it expected to run for?
November 2013 to April 2015.
Who is funding the study?
NHS Greater Glasgow & Clyde Endowment Fund (UK).
Who is the main contact?
Dr Adrian Stanley
adrian.stanley@ggc.scot.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Adrian Stanley
ORCID ID
Contact details
GI Unit
Walton Building
Glasgow Royal Infirmary
Castle Street
Glasgow
G4 OSF
United Kingdom
+44 (0)141 211 4073
adrian.stanley@ggc.scot.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
145837
Study information
Scientific title
International multicentre prospective study to compare risk scoring system for patients presenting with upper gastrointestinal bleeding
Acronym
Study hypothesis
To compare the ability of five existing risk scoring systems (the Full and Clinical Rockall scores, the Italian PNED score, the Glasgow Blatchford (GBS) and the American AIM65 score) to predict outcomes in upper gastrointestinal bleeding (UGIB):
1. Need for hospital-based intervention or mortality
2. Rebleeding within 7 days
3. Length of hospital stay
4. 30-day mortality.
Ethics approval
West of Scotland Research Ethics Service, 15/01/2014, REC ref: 14/WS/0012, IRAS project ID: 145837
Study design
International observational study
Primary study design
Observational
Secondary study design
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Upper gastrointestinal bleeding (UGIB)
Intervention
This is an international observational study across seven international sites, to compare five established risk assessment scores in the prediction of clinical outcomes for patients presenting with UGIB. We will collect data to calculate these scores for each patient, then compare the scores' ability to predict the pre-determined end-points.
There are no interventions. We will simply collate data on presentation to hospital with UGIB to allow measurement of the recognised risk scoring systems for this condition. We will then follow up the patients to determine outcomes as described above in the study hypothesis section.
Intervention type
Phase
Drug names
Primary outcome measures
Need for hospital-based intervention or 30-day mortality on follow-up
Secondary outcome measures
1. Rebleeding within 7 days
2. Length of hospital stay
Overall trial start date
01/11/2013
Overall trial end date
30/04/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients presenting with haematemesis, coffee-ground vomit, melaena
2. Patients presenting with haematochezia and circulatory insufficiency (heart rate >100 bpm and/or systolic blood pressure <100 mmHg)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3000
Participant exclusion criteria
Patients who have an UGIB whilst already an in-patient for other reasons
Recruitment start date
04/03/2014
Recruitment end date
30/03/2015
Locations
Countries of recruitment
Canada, Denmark, Italy, New Zealand, Singapore, United Kingdom, United States of America
Trial participating centre
Glasgow Royal Infirmary
G4 OSF
United Kingdom
Trial participating centre
Yale University Hospital
CT 06516
United States of America
Trial participating centre
Odense University Hospital
DK 5000
Denmark
Trial participating centre
Royal Cornwall Hospital
TR1 3GZ
United Kingdom
Trial participating centre
Singapore General Hospital
169608
Singapore
Trial participating centre
Dunedin Public Hospital
9054
New Zealand
Trial participating centre
Humanitas Research Hospital
20089
Italy
Trial participating centre
University Hospital, London
N6A SW9
Canada
Funders
Funder type
Government
Funder name
NHS Greater Glasgow & Clyde Endowment Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results of the study will be presented at international conferences in gastroenterology and will be published in an international peer-reviewed journal.
Intention to publish date
Participant level data
Stored in repository
Results - basic reporting
Publication summary