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NCT Number: NCT06945328

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

* 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upper Endoscopy

Procedure

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

Primary outcomes

  1. Association between non-variceal UGIB and the use of different drugs

    Time frame: 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 outcomes

  1. The severity of Non-variceal bleeding related to specified drugs.

    Time frame: through study completion, an average of 1 year

    To compare the severity of Non-variceal bleeding related to specified drugs, according to Rockall Score

  2. Risk factors associated with non-variceal upper gastrointestinal bleeding

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Ezz-Eldin Abd-Elmoneim, Lecturer

CONTACT

[email protected]

+201018590854

Nada Abdelfattah Ahmed Abdelatty, Resident doctor

CONTACT

[email protected]

+201006962358

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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