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OpenTrials
Completed

NCT Number: NCT01155401

Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: About 1 year

Secondary outcomes

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

    Time frame: About 1 year

  2. 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

    Time frame: About 1 year

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

    Time frame: About 1 year

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 1, 2010
Registry last updated
Nov 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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