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Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

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ClinicalTrials.gov Identifier: NCT01155401
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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

Condition or disease
Upper Gastrointestinal Bleeding

Study Design
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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding
Study Start Date : June 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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Groups and Cohorts
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Group/Cohort
1
Patients with acute upper gastrointestinal bleeding


Outcome Measures
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Primary Outcome Measures :
  1. Number and percentage of patients with drug-induced upper gastrointestinal bleeding [ Time Frame: About 1 year ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155401


Locations
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Russian Federation
Research Site
Moscow, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Boris R Gelfand, Prof Department of the Russian State Medical University
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01155401    
Other Study ID Numbers: NIS-GRU-NEX-2009/2
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011
Keywords provided by AstraZeneca:
acute upper gastrointestinal bleeding
patients with drug-induced upper gastrointestinal bleeding
routine management
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases