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

April 24, 2025 updated by: Nada Abdelfattah Ahmed, Assiut University
  • 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mohammed Ezz-Eldin Abd-Elmoneim, Lecturer
  • Phone Number: +201018590854
  • Email: M.ezz@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gastrointestinal Bleeding

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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