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Study of Patients With Drug-induced Non-variceal Upper Gastrointestinal Bleeding

Study of Patients With Drug-induced Non-variceal Upper Gastrointestinal Bleeding

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06945328
Enrollment
100
Registered
2025-04-25
Start date
2025-05-31
Completion date
2026-02-28
Last updated
2025-04-27

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

Conditions

Upper Gastrointestinal Bleeding (UGIB)

Brief 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.

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.

Interventions

PROCEDUREUpper endoscopy

All patients will do gastroscopy (upper endoscopy) within the first 24 hour of admission and specific elements of bleeding

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adult patients (aged 18 years and above) presented with signs and symptoms of UGIB (hematemesis and/or melena)

Exclusion criteria

* Variceal bleeding * Age below 18 years * Pregnant women * Consent refusal

Design outcomes

Primary

MeasureTime frameDescription
Association between non-variceal UGIB and the use of different drugsthrough study completion, an average of 1 yearobservation the association between the incedience of Non-variceal upper Gastrointestinal Bleeding and the use of NSAIDs, VKAs, DOACs and antiplatelet therapy

Secondary

MeasureTime frameDescription
The severity of Non-variceal bleeding related to specified drugs.through study completion, an average of 1 yearTo compare the severity of Non-variceal bleeding related to specified drugs, according to Rockall Score
Risk factors associated with non-variceal upper gastrointestinal bleedingthrough study completion, an average of 1 yearWe 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.

Contacts

Primary ContactNada Abdelfattah Ahmed Abdelatty, Resident doctor
Nadabdelfattah@gmail.com+201006962358
Backup ContactMohammed Ezz-Eldin Abd-Elmoneim, Lecturer
M.ezz@aun.edu.eg+201018590854

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026