Causes and outcomes of internal bleeding in the digestive system
| ISRCTN | ISRCTN14750381 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14750381 |
- Submission date
- 31/08/2018
- Registration date
- 06/11/2018
- Last edited
- 05/06/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
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.
Contact information
Scientific
Department of Gastroenterology
University Hospital Crosshhouse
Kilmarnock
KA2 0BE
United Kingdom
| Phone | 44-1563-827280 |
|---|---|
| ali.taha1@btinternet.com |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Assessments of epidemiology, aetiology, and outcomes of gastrointestinal bleeding |
| Study objectives | 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(s) | 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. The Manager of the West of Scotland Research Ethics Service had advised that "If the purpose of the study is more of a service evaluation, looking at outcomes, etc., then as audit/service evaluation we would not require ethical review. Consent is good to have but where you are not able to secure consent for retrospective data then access to the data should be appropriately controlled. If it is your own clinical data this is not usually an issue however anyone outside of the routine clinical care team should only access anonymised data. If you are getting data from outside of NHS Ayrshire and Arran then this would require PBPP approval. For the prospective cases you are looking to seek consent for the use of anonymised data which is best practice." |
| Health condition(s) or problem(s) studied | 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 |
| 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 overt 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 study start date | 01/01/2002 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | All patients presenting with gastrointestinal bleeding, 1996-2026, average 300 patients per annum. |
| Key inclusion criteria | 1. Aged 18 years or older 2. Gastrointestinal bleeding |
| Key exclusion criteria | 1. History of previous gastrointestinal surgery 2. Current pregnancy 3. Current use of cytotoxic drugs |
| Date of first enrolment | 15/09/2018 |
| Date of final enrolment | 15/09/2026 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Kilmarnock
KA2 0BE
United Kingdom
Sponsor information
Hospital/treatment centre
University Hospital Crosshouse
Kilmarnock
KA2 0BE
Scotland
United Kingdom
"ROR" |
https://ror.org/041f0qb31 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Poster results | abstract/poster | 01/05/2020 | 22/01/2021 | No | No |
Editorial Notes
05/06/2024: The intention to publish date was changed from 30/06/2021 to 30/06/2027.
04/06/2024: Ethics approval details added.
30/05/2023: The upper and lower age limits have been added.
27/01/2021: IPD sharing statement added.
22/01/2021: Abstract/poster added.
11/12/2020: The following changes were made to the trial record:
1. The study design was changed.
2. The primary outcome measure was changed.
3. The intention to publish date was changed from 30/06/2020 to 30/06/2021.
09/07/2020: The trial contact details have been made publicly visible.
12/12/2019: The intention to publish date has been changed from 01/06/2019 to 30/06/2020.
23/11/2018: Internal review.
