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

NCT06945328 | Not Yet Recruiting DMC

• 1 other identifier: Gastrointestinal Bleeding
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Upper Gastrointestinal Bleeding (UGIB)

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

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

  through study completion, an average of 1 year

• Risk factors associated with non-variceal upper gastrointestinal bleeding

  through study completion, an average of 1 year

Interventions

Upper endoscopy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Adult patients (aged 18 years and above) presented with signs and symptoms of UGIB (hematemesis and/or melena)

You may not qualify if:

• Variceal bleeding
• Age below 18 years
• Pregnant women
• Consent refusal

Sponsors & Collaborators

• Assiut University: lead

Related Publications (10)

• 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.

  PMID: 19104934 BACKGROUND

• 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.

  PMID: 9414965 BACKGROUND

• 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.

  PMID: 28700711 BACKGROUND

• 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.

  PMID: 35078371 BACKGROUND

• 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.

  PMID: 30559261 BACKGROUND

• 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.

  PMID: 24755148 BACKGROUND

• 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.

  PMID: 28128753 BACKGROUND

• 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.

  PMID: 31352454 BACKGROUND

• 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.

  PMID: 21490373 BACKGROUND

• 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.

  PMID: 17101296 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Nada Abdelfattah Ahmed Abdelatty, Resident doctor

CONTACT

+201006962358; Nadabdelfattah@gmail.com

Mohammed Ezz-Eldin Abd-Elmoneim, Lecturer

CONTACT

+201018590854; M.ezz@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 25, 2025
• Study Start: May 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04