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

Not yet recruiting

• Conditions: Upper Gastrointestinal Bleeding (UGIB)

• Registration Number: NCT06945328
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-04-25
• Last Update Posted: 2025-04-27
• Study Start: 2025-05
• Primary Completion: 2026-01
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between non-variceal UGIB and the use of different drugs	through study completion, an average of 1 year	observation the association between the incedience of Non-variceal upper Gastrointestinal Bleeding and the use of NSAIDs, VKAs, DOACs and antiplatelet therapy

Secondary Outcome Measures

Name	Time	Method
The severity of Non-variceal bleeding related to specified drugs.	through study completion, an average of 1 year	To compare the severity of Non-variceal bleeding related to specified drugs, according to Rockall Score
Risk factors associated with non-variceal upper gastrointestinal bleeding	through study completion, an average of 1 year	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.