Causes and outcomes of internal bleeding in the digestive system

Assessments of epidemiology, aetiology, and outcomes of gastrointestinal bleeding

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN14750381

Enrollment

9000

Registered

2018-11-06

Start date

2018-09-15

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal bleeding Digestive System Gastrointestinal bleeding

Interventions

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,

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. Gastrointestinal bleeding

Exclusion criteria

Exclusion criteria: 1. History of previous gastrointestinal surgery 2. Current pregnancy 3. Current use of cytotoxic drugs

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 1, 2026