Condition category
Digestive System
Date applied
31/08/2018
Date assigned
06/11/2018
Last edited
23/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

N/A

Contact information

Type

Scientific

Primary contact

Prof Ali Taha

ORCID ID

Contact details

Department of Gastroenterology
University Hospital Crosshhouse
Kilmarnock
KA2 0BE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Assessments of epidemiology, aetiology, and outcomes of gastrointestinal bleeding

Acronym

N/A

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

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

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

Sponsor information

Organisation

Gastroenterology Endowment Fund

Sponsor details

University Hospital Crosshouse
Kilmarnock
KA2 0BE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

01/06/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/11/2018: Internal review.