Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01155401
First received: June 25, 2010
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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
Upper Gastrointestinal Bleeding

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number and percentage of patients with drug-induced upper gastrointestinal bleeding [ Time Frame: About 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and percentage of patients with each symptom and each Forrest class of upper gastrointestinal bleeding [ Time Frame: About 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number and percentage of patients with each type of bleeding outcomes who received different types of hemostatic therapy [ Time Frame: About 1 year ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with acute upper gastrointestinal bleeding

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155401

Locations
Russian Federation
Research Site
Moscow, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Boris R Gelfand, Prof Department of the Russian State Medical University
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01155401     History of Changes
Other Study ID Numbers: NIS-GRU-NEX-2009/2
Study First Received: June 25, 2010
Last Updated: November 7, 2011
Health Authority: Russia: Ethics Committee

Keywords provided by AstraZeneca:
acute upper gastrointestinal bleeding
patients with drug-induced upper gastrointestinal bleeding
routine management

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014