Upper Gastrointestinal Bleeding (UGIB)NCT06945328
Study of Patients With Drug-induced Non-variceal Upper Gastrointestinal Bleeding
An observational study of Upper Gastrointestinal Bleeding (UGIB), run by Assiut University.
Trial summary
To study the association between non-variceal UGIB and the use of NSAIDs, VKAs, DOACs and antiplatelet therapy. To compare the severity of bleeding related to specified drugs. To determine risk factors associated with non-variceal UGIB. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Gastrointestinal Bleeding (UGIB)
- What is being tested?
- Upper endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Feb 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (aged 18 years and above) presented either to the emergency or the outpatient department with signs and symptoms of UGIB (hematemesis and/or melena) who are on the specified medications (NSAIDs, VKAs, DOACs and antiplatelet therapy).
Who may be able to join
- Adult patients (aged 18 years and above) presented with signs and symptoms of UGIB (hematemesis and/or melena)
Who cannot join
- Variceal bleeding
- Age below 18 years
- Pregnant women
- Consent refusal
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- To study the association between non-variceal UGIB and the use of NSAIDs, VKAs, DOACs and antiplatelet therapy.
- To compare the severity of bleeding related to specified drugs.
- To determine risk factors associated with non-variceal UGIB.
Read the detailed description
Upper gastrointestinal bleeding (UGIB) carries a high mortality, especially in elderly patients having co-morbidities, and the incidence of non-variceal and variceal bleeding is reported to be 3.5% and 15%, respectively.
Atrial fibrillation, deep vein thrombosis, pulmonary embolism, and other conditions require anticoagulation, non-steroidal anti-inflammatory drugs (NSAIDs) and antiplatelet therapy putting the patients at high risk of hemorrhage.
The latest American Heart Association (AHA) report on cardiovascular diseases suggests a doubling of the prevalence of atrial fibrillation by 2030 compared to 2010. The need to institute anticoagulation for this condition, both as primary and secondary prevention, will automatically increase the number of UGIB cases. An improvement in this regard has occurred with the advent of direct oral anticoagulants (DOACs) which have been shown to be non-inferior to vitamin K antagonists (VKAs).
In the event of UGIB, the Rockall score is a valid prediction score, repeatedly confirmed to assess the risk of patients with non-variceal bleeding. The management of UGIB is commonly adapted according to this score. Identifying high-risk patients who may benefit from longer hospitalization is crucial.
- Conditions
- Upper Gastrointestinal Bleeding (UGIB)
- Being tested
- Upper endoscopy
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper endoscopyProcedure or surgery
All patients will do gastroscopy (upper endoscopy) within the first 24 hour of admission and specific elements of bleeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between non-variceal UGIB and the use of different drugs
observation the association between the incedience of Non-variceal upper Gastrointestinal Bleeding and the use of NSAIDs, VKAs, DOACs and antiplatelet therapy
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
The severity of Non-variceal bleeding related to specified drugs.
To compare the severity of Non-variceal bleeding related to specified drugs, according to Rockall Score
Measured: through study completion, an average of 1 year
Risk factors associated with non-variceal upper gastrointestinal bleeding
We will determine risk factors associated with With non-varicreal gastrointestinal bleeding, such as demographic data, smoking , co-morbidities ، dose and duration of specified drugs, and presence of h pylori infection.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal Bleeding (UGIB)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Abdelfattah Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945328
- Sponsor's protocol ID
- Gastrointestinal Bleeding
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim BJ, Park MK, Kim SJ, Kim ER, Min BH, Son HJ, Rhee PL, Kim JJ, Rhee JC, Lee JH. Comparison of scoring systems for the prediction of outcomes in patients with nonvariceal upper gastrointestinal bleeding: a prospective study. Dig Dis Sci. 2009 Nov;54(11):2523-9. doi: 10.1007/s10620-008-0654-7. Epub 2008 Dec 23.
PubMed 19104934Rockall TA, Logan RF, Devlin HB, Northfield TC. Influencing the practice and outcome in acute upper gastrointestinal haemorrhage. Steering Committee of the National Audit of Acute Upper Gastrointestinal Haemorrhage. Gut. 1997 Nov;41(5):606-11. doi: 10.1136/gut.41.5.606.
PubMed 9414965Sjogren V, Bystrom B, Renlund H, Svensson PJ, Oldgren J, Norrving B, Sjalander A. Non-vitamin K oral anticoagulants are non-inferior for stroke prevention but cause fewer major bleedings than well-managed warfarin: A retrospective register study. PLoS One. 2017 Jul 10;12(7):e0181000. doi: 10.1371/journal.pone.0181000. eCollection 2017.
PubMed 28700711Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
PubMed 35078371Piran S, Schulman S. Treatment of bleeding complications in patients on anticoagulant therapy. Blood. 2019 Jan 31;133(5):425-435. doi: 10.1182/blood-2018-06-820746. Epub 2018 Dec 17.
PubMed 30559261Piccini JP, Hellkamp AS, Lokhnygina Y, Patel MR, Harrell FE, Singer DE, Becker RC, Breithardt G, Halperin JL, Hankey GJ, Berkowitz SD, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Investigators. Relationship between time in therapeutic range and comparative treatment effect of rivaroxaban and warfarin: results from the ROCKET AF trial. J Am Heart Assoc. 2014 Apr 22;3(2):e000521. doi: 10.1161/JAHA.113.000521.
PubMed 24755148Ullrich H, Gori T. Antiplatelet therapies in patients with an indication for anticoagulation. Clin Hemorheol Microcirc. 2016;64(3):273-278. doi: 10.3233/CH-168104.
PubMed 28128753Steffel J. Stroke Prevention with Non-Vitamin K Oral Anticoagulants: For Most, but Not for All! Cardiology. 2019;143(3-4):121-123. doi: 10.1159/000501586. Epub 2019 Jul 26. No abstract available.
PubMed 31352454Hearnshaw SA, Logan RF, Lowe D, Travis SP, Murphy MF, Palmer KR. Acute upper gastrointestinal bleeding in the UK: patient characteristics, diagnoses and outcomes in the 2007 UK audit. Gut. 2011 Oct;60(10):1327-35. doi: 10.1136/gut.2010.228437. Epub 2011 Apr 13.
PubMed 21490373Targownik LE, Nabalamba A. Trends in management and outcomes of acute nonvariceal upper gastrointestinal bleeding: 1993-2003. Clin Gastroenterol Hepatol. 2006 Dec;4(12):1459-1466. doi: 10.1016/j.cgh.2006.08.018. Epub 2006 Nov 13.
PubMed 17101296