International comparison of methods to risk assess patients presenting with upper gastrointestinal bleeding
| ISRCTN | ISRCTN16235737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16235737 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 145837 |
| Protocol serial number | IRAS 145837 |
| Sponsor | NHS Greater Glasgow & Clyde (UK) |
| Funder | NHS Greater Glasgow & Clyde Endowment Fund (UK) |
- Submission date
- 29/09/2015
- Registration date
- 29/09/2015
- Last edited
- 10/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
GI Unit, Walton Building
Glasgow Royal Infirmary
Castle Street
Glasgow
G4 OSF
United Kingdom
| Phone | +44 (0)141 211 4073 |
|---|---|
| adrian.stanley@ggc.scot.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | International observational study |
| Secondary study design | |
| Scientific title | International multicentre prospective study to compare risk scoring system for patients presenting with upper gastrointestinal bleeding |
| Study objectives | 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(s) | West of Scotland Research Ethics Service, 15/01/2014, REC ref: 14/WS/0012, IRAS project ID: 145837 |
| Health condition(s) or problem(s) studied | 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 | Other |
| Primary outcome measure(s) |
Need for hospital-based intervention or 30-day mortality on follow-up |
| Key secondary outcome measure(s) |
1. Rebleeding within 7 days |
| Completion date | 30/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 3000 |
| Total final enrolment | 3012 |
| Key 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) |
| Key exclusion criteria | Patients who have an UGIB whilst already an in-patient for other reasons |
| Date of first enrolment | 04/03/2014 |
| Date of final enrolment | 30/03/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
- Canada
- Denmark
- Italy
- New Zealand
- Singapore
- United States of America
Study participating centres
United Kingdom
United States of America
Denmark
United Kingdom
Singapore
New Zealand
Italy
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/01/2017 | Yes | No | |
| Results article | results | 01/02/2019 | 01/04/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/10/2023: Total final enrolment added.
01/04/2020: Publication reference added.
19/01/2018: Publication reference added.
