NCT06945328

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Upper Gastrointestinal Bleeding (UGIB)

Interventions

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

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2025-04-25
• Last updated: 2025-04-27