Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

NCT01155401 | Completed

• 1 other identifier: NIS-GRU-NEX-2009/2
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine and analyse the incidence, severity, risk factors and routine management of acute drug-induced upper gastrointestinal bleeding (UGIB) in the population of Russian patients

Conditions

Upper Gastrointestinal Bleeding

Keywords

acute upper gastrointestinal bleeding; patients with drug-induced upper gastrointestinal bleeding; routine management

Outcome Measures

Primary Outcomes (1)

• Number and percentage of patients with drug-induced upper gastrointestinal bleeding

  About 1 year

Secondary Outcomes (3)

• Number and percentage of patients with each symptom and each Forrest class of upper gastrointestinal bleeding

  About 1 year

• Number and percentage of patients with concomitant diseases contributing to drug-induced upper gastrointestinal bleeding and those who receive NSAIDs, antiplatelet agents, anticoagulants, steroids or combination therapy

  About 1 year

• Number and percentage of patients with each type of bleeding outcomes who received different types of hemostatic therapy

  About 1 year

Study Arms (1)

1

Patients with acute upper gastrointestinal bleeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic

You may qualify if:

• Established diagnosis of acute upper gastrointestinal bleeding, confirmed by presence of hematemesis/ coffee ground vomiting, melena, as well as other clinical or laboratory evidence of acute blood loss from the upper gastrointestinal tract
• Written informed consent provided prior the start of participation in the study.

You may not qualify if:

• Subjects who are unwilling or unable to provide informed consent.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Moscow, Russia

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Boris R Gelfand, Prof

  Department of the Russian State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: July 1, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

RU (1)