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Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

Completed
Conditions
Upper Gastrointestinal Bleeding
Registration Number
NCT01155401
Lead Sponsor
AstraZeneca
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
300
Inclusion Criteria
  • 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.
Exclusion Criteria
  • Subjects who are unwilling or unable to provide informed consent.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number and percentage of patients with drug-induced upper gastrointestinal bleedingAbout 1 year
Secondary Outcome Measures
NameTimeMethod
Number and percentage of patients with each symptom and each Forrest class of upper gastrointestinal bleedingAbout 1 year
Number and percentage of patients with each type of bleeding outcomes who received different types of hemostatic therapyAbout 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 therapyAbout 1 year

Trial Locations

Locations (1)

Research Site

🇷🇺

Moscow, Russian Federation

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