Study of Patients With Drug-induced Non-variceal Upper Gastrointestinal Bleeding
NCT ID: NCT06945328
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2025-05-31
2026-02-28
Brief Summary
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* To compare the severity of bleeding related to specified drugs.
* To determine risk factors associated with non-variceal UGIB.
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Detailed Description
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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
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Study Design
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OTHER
CROSS_SECTIONAL
Interventions
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Upper endoscopy
All patients will do gastroscopy (upper endoscopy) within the first 24 hour of admission and specific elements of bleeding
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Age below 18 years
* Pregnant women
* Consent refusal
18 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Nada Abdelfattah Ahmed
Principal investigator
Central Contacts
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References
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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.
Rockall TA, Logan RF, Devlin HB, Northfield TC. Influencing the practice and outcome in acute upper gastrointestinal haemorrhage. Steering Committee of the National Audit of Acute Upper Gastrointestinal Haemorrhage. Gut. 1997 Nov;41(5):606-11. doi: 10.1136/gut.41.5.606.
Sjogren V, Bystrom B, Renlund H, Svensson PJ, Oldgren J, Norrving B, Sjalander A. Non-vitamin K oral anticoagulants are non-inferior for stroke prevention but cause fewer major bleedings than well-managed warfarin: A retrospective register study. PLoS One. 2017 Jul 10;12(7):e0181000. doi: 10.1371/journal.pone.0181000. eCollection 2017.
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.
Piran S, Schulman S. Treatment of bleeding complications in patients on anticoagulant therapy. Blood. 2019 Jan 31;133(5):425-435. doi: 10.1182/blood-2018-06-820746. Epub 2018 Dec 17.
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.
Ullrich H, Gori T. Antiplatelet therapies in patients with an indication for anticoagulation. Clin Hemorheol Microcirc. 2016;64(3):273-278. doi: 10.3233/CH-168104.
Steffel J. Stroke Prevention with Non-Vitamin K Oral Anticoagulants: For Most, but Not for All! Cardiology. 2019;143(3-4):121-123. doi: 10.1159/000501586. Epub 2019 Jul 26. No abstract available.
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.
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.
Other Identifiers
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Gastrointestinal Bleeding
Identifier Type: -
Identifier Source: org_study_id
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