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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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23 October 2023 |
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Main ID: |
ISRCTN16235737 |
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Date of registration:
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29/09/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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International comparison of methods to risk assess patients presenting with upper gastrointestinal bleeding
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Scientific title:
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International multicentre prospective study to compare risk scoring system for patients presenting with upper gastrointestinal bleeding |
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Date of first enrolment:
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04/03/2014 |
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Target sample size:
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3000 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN16235737 |
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Study type:
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Observational |
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Study design:
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International observational study (Diagnostic)
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Phase:
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Not Applicable
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Countries of recruitment
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Canada
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Denmark
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England
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Italy
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New Zealand
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Singapore
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United Kingdom
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United States of America
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Contacts
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Name:
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Adrian
Stanley |
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Address:
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GI Unit, Walton Building
Glasgow Royal Infirmary
Castle Street
G4 OSF
Glasgow
United Kingdom |
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Telephone:
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+44 (0)141 211 4073 |
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Email:
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adrian.stanley@ggc.scot.nhs.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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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)
Exclusion criteria: Patients who have an UGIB whilst already an in-patient for other reasons
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Upper gastrointestinal bleeding (UGIB)
Digestive System
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Intervention(s)
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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.
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Primary Outcome(s)
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Need for hospital-based intervention or 30-day mortality on follow-up
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Secondary Outcome(s)
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1. Rebleeding within 7 days
2. Length of hospital stay
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Secondary ID(s)
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IRAS 145837
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Nil known
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Source(s) of Monetary Support
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NHS Greater Glasgow & Clyde Endowment Fund (UK)
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; West of Scotland Research Ethics Service, 15/01/2014, REC ref: 14/WS/0012, IRAS project ID: 145837
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/04/2015 |
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URL:
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