Plain English Summary
Background and aims
Internal bleeding from the stomach and the gut may show as vomiting up blood. It may also show as passing blood in the toilet. Sometimes you can see the blood clearly in the toilet, and sometimes it is there but it cannot be seen. This study aims to determine if this internal bleeding changes from year to year - whetjher it changes with age, smoking, and use of alcohol, and whether it changes with the use of certain drugs.
Who can participate:
Adults suffering from internal stomach or gut bleeding
What does the study involve?
There will be no direct participation from participants, as this study is a review of previous cases of internal bleeding (1996 to present) and new cases from now until 2026. Patient details will be kept confidential and anonymous. Records will be reviewed for changes in various factors over time, including patient demographics, other illness, causes and nature of bleeding, drugs taken and whether patients have had surgery, amongst various other factors.
What are the possible benefits and risks of participating?
The possible benefit of taking part in this study is that the results could improve future treatment of patients with internal bleeding, and this may help to train doctors. There are no known risks to participants taking part in this study, as it does not require direct participation.
Where is the study run from?
Gastroenterology Unit at University Hospital Crosshouse, Kilmarnock, Scotland (UK)
When is the study starting and how long is it expected to run for?
January 2002 to December 2026
Who is funding the study?
Gastroenterology Endowment Fund, University Hospital Crosshouse, NHS Ayrshire and Arran, Scotland (UK)
Who is the main contact?
Professor Ali S Taha
ali.taha1@btinternet.com.
Trial website
Contact information
Type
Scientific
Primary contact
Prof Ali Taha
ORCID ID
Contact details
Department of Gastroenterology
University Hospital Crosshhouse
Kilmarnock
KA2 0BE
United Kingdom
44-1563-827280
ali.taha1@btinternet.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Assessments of epidemiology, aetiology, and outcomes of gastrointestinal bleeding
Acronym
Study hypothesis
The epidemiology, aetiology, and outcomes of gastrointestinal bleeding continue to change as a reflection of the increasing use of both mucosal damaging and protective agents. Damaging agents include non-steroidal anti-inflammatory drugs, aspirin, old and new anti-thrombotic drugs given as part of cardio-vascular protective strategies. Mucosal protective drugs mainly include proton-pump inhibitors.
Ethics approval
These audit assessments have been approved by the Information Governance Office, on behalf of the Caldicott Guardian, NHS Ayrshire and Arran, Scotland. They do not require ethics approval due to their audit nature.
Study design
Current study design as of 11/12/2020:
Prospective and Retrospective observational epidemiology study - audit assessments of causes and outcomes of gastrointestinal bleeding over a 30-year period (1996-2026)
Previous study design:
Observational epidemiology study - audit assessments of causes and outcomes of gastrointestinal bleeding over a 30-year period (1996-2026)
Primary study design
Observational
Secondary study design
Epidemiological study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Gastrointestinal bleeding
Intervention
Patients' details will be anonymised. From their medical records, the following will be analysed:
1. Demography
2. Coexisting conditions
3. Drug therapy
4. Nature of gastrointestinal bleeding (overt, obscure, etc)
5. Length of hospital stay
6. Causes of bleeding
7. Need for transfusion
8. Use of acid inhibitors
9. Need for surgery
10. Other complications of gastrointestinal bleeding
11. Re-bleeding
12. Factors that might help stop bleeding and prevent re-bleeding
12. All-cause mortality
Intervention type
Other
Phase
Drug names
Primary outcome measure
Current primary outcome measure as of 11/12/2020:
Time trends of the following will be assessed through a review of patient medical records:
1. Demography
2. Coexisting conditions including COVID-19
3. Drug therapy
4. Nature of gastrointestinal bleeding (overt, obscure, etc)
5. Length of hospital stay
6. Causes of bleeding
7. Need for transfusion
8. Use of acid inhibitors
9. Need for surgery
10. Other complications of gastrointestinal bleeding
11. Re-bleeding
12. Factors that might help stop bleeding and prevent re-bleeding
13. All-cause mortality including COVID-19
_____
Previous primary outcome measure:
Time trends of the following will be assessed through a review of patient medical records:
1. Demography
2. Coexisting conditions
3. Drug therapy
4. Nature of gastrointestinal bleeding (overt, obscure, etc)
5. Length of hospital stay
6. Causes of bleeding
7. Need for transfusion
8. Use of acid inhibitors
9. Need for surgery
10. Other complications of gastrointestinal bleeding
11. Re-bleeding
12. Factors that might help stop bleeding and prevent re-bleeding
12. All-cause mortality
Secondary outcome measures
Subgroup analysis of factors included in the primary outcomes:
1. Role of demographic factors, particularly smoking and alcohol: presence vs. absence.
2. Role of drugs (users vs. non-users), particularly:
2.1. NSAIDs
2.2. Aspirin
2.3. Other anti-platelet agents
2.4. Anticoagulants
2.5. Acid inhibitors
3. Re-admissions following initial bleeding and relevant causative factors
4. Endoscopic findings in upper and lower gastrointestinal tract in cases of over bleeding
5. Endoscopic findings in obscure bleeding
6. Colonic polyps and cancers in obscure bleeding, bowel screening, and the use of aspirin and NSAIDs
Overall trial start date
01/01/2002
Overall trial end date
31/12/2026
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or older
2. Gastrointestinal bleedibng
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
All patients presenting with gastrointestinal bleeding, 1996-2026, average 300 patients per annum.
Participant exclusion criteria
1. History of previous gastrointestinal surgery
2. Current pregnancy
3. Current use of cytotoxic drugs
Recruitment start date
15/09/2018
Recruitment end date
15/09/2026
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Gastroenterology
University Hospital Crosshouse
Kilmarnock
KA2 0BE
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Gastroenterology Endowment Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Regular analyses will take place, possibly at yearly or shorter intervals. The outcomes will be presented locally and at meetings of learned societies. Publishing in peer reviewed journals will be considered and aimed for, as appropriate. Our first publication might be ready in the Summer of 2019.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
30/06/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2020 abstract/poster in https://doi.org/10.1016/s0016-5085%2820%2932157-0 (added 22/01/2021)