Condition category
Digestive System
Date applied
29/09/2015
Date assigned
29/09/2015
Last edited
29/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

NHS Greater Glasgow & Clyde (UK)

Sponsor details

R&D Management Office
Western Infirmary
Tennant Institute
38 Church Street
Glasgow
G11 6NT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes