Clinical trial NCT06945328: Study of Patients With Drug-induced Non-variceal Upper Gastrointestinal Bleeding
Official title: Study of Patients With Drug-induced Non-variceal Upper Gastrointestinal Bleeding
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Upper Gastrointestinal Bleeding (UGIB)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between non-variceal UGIB and the use of different drugs
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The severity of Non-variceal bleeding related to specified drugs.
timeFrame: through study completion, an average of 1 year
measure: Risk factors associated with non-variceal upper gastrointestinal bleeding
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Kim BJ, Park MK, Kim SJ, Kim ER, Min BH, Son HJ, Rhee PL, Kim JJ, Rhee JC, Lee JH. Comparison of scoring systems for the prediction of outcomes in patients with nonvariceal upper gastrointestinal bleeding: a prospective study. Dig Dis Sci. 2009 Nov;54(11):2523-9. doi: 10.1007/s10620-008-0654-7. Epub 2008 Dec 23.
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citation: Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
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citation: Piccini JP, Hellkamp AS, Lokhnygina Y, Patel MR, Harrell FE, Singer DE, Becker RC, Breithardt G, Halperin JL, Hankey GJ, Berkowitz SD, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Investigators. Relationship between time in therapeutic range and comparative treatment effect of rivaroxaban and warfarin: results from the ROCKET AF trial. J Am Heart Assoc. 2014 Apr 22;3(2):e000521. doi: 10.1161/JAHA.113.000521.
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citation: Hearnshaw SA, Logan RF, Lowe D, Travis SP, Murphy MF, Palmer KR. Acute upper gastrointestinal bleeding in the UK: patient characteristics, diagnoses and outcomes in the 2007 UK audit. Gut. 2011 Oct;60(10):1327-35. doi: 10.1136/gut.2010.228437. Epub 2011 Apr 13.
citation: Targownik LE, Nabalamba A. Trends in management and outcomes of acute nonvariceal upper gastrointestinal bleeding: 1993-2003. Clin Gastroenterol Hepatol. 2006 Dec;4(12):1459-1466. doi: 10.1016/j.cgh.2006.08.018. Epub 2006 Nov 13.