Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01155401

Enrollment

300

Registered

2010-07-01

Start date

2010-06-30

Completion date

2011-06-30

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Gastrointestinal Bleeding

Keywords

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

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number and percentage of patients with drug-induced upper gastrointestinal bleeding	About 1 year

Secondary

Measure	Time frame
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

Countries

Russia

Outcome results