check_circleStudy Completed
Gastrointestinal bleedings
Bayer Identifier:
19549
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
An observational study, called GIBSON, to learn more about the trends and risk-factors of bleeding in the digestive tract in the Finnish population
Trial purpose
This is an observational study in which patient data from the past of adults in Finland who have had bleeding in the digestive tract are collected and studied.
In observational studies, only observations are made without specified advice or interventions. No visits or tests are required.
Bleeding in the digestive tract, also called gastrointestinal bleeding (GIB), can occur anywhere in the digestive tract. They are called upper gastrointestinal bleeding (UGIB) when they occur in the esophagus, stomach, or upper part of the small intestine, and lower gastrointestinal bleeding (LGIB) when they occur in the small or large intestine. Risk factors of GIB include smoking, alcohol use, various diseases, or older age. In addition, GIBs are known side effects of certain drugs such as blood thinners, drugs given for pain and fever (non-steroidal anti-inflammatory drugs), or for depression and anxiety (selective serotonin reuptake inhibitors). To better understand the impact of these drugs on GIBs and the impact of other risk factors, more knowledge is needed about GIBs and the various risk factors in the general population.
The main purpose of this study is to learn more about the occurrence and risk factors of GIBs in the Finish population aged 25 to 74 years.
To do this, researchers will collect data from a Finnish survey and other sources of health data to find out the number of people who had UGIB or LGIB. In addition, characteristics of people with GIB and their risk factors will be studied.
The collected data will cover the period from 1987 to 2016 (depending on availability).
In observational studies, only observations are made without specified advice or interventions. No visits or tests are required.
Bleeding in the digestive tract, also called gastrointestinal bleeding (GIB), can occur anywhere in the digestive tract. They are called upper gastrointestinal bleeding (UGIB) when they occur in the esophagus, stomach, or upper part of the small intestine, and lower gastrointestinal bleeding (LGIB) when they occur in the small or large intestine. Risk factors of GIB include smoking, alcohol use, various diseases, or older age. In addition, GIBs are known side effects of certain drugs such as blood thinners, drugs given for pain and fever (non-steroidal anti-inflammatory drugs), or for depression and anxiety (selective serotonin reuptake inhibitors). To better understand the impact of these drugs on GIBs and the impact of other risk factors, more knowledge is needed about GIBs and the various risk factors in the general population.
The main purpose of this study is to learn more about the occurrence and risk factors of GIBs in the Finish population aged 25 to 74 years.
To do this, researchers will collect data from a Finnish survey and other sources of health data to find out the number of people who had UGIB or LGIB. In addition, characteristics of people with GIB and their risk factors will be studied.
The collected data will cover the period from 1987 to 2016 (depending on availability).
Key Participants Requirements
Sex
AllAge
25 - 74 YearsTrial summary
Enrollment Goal
39054Trial Dates
September 2018 - October 2021Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, Finland |
Primary Outcome
- Incidence rate of major gastrointestinal bleedings (GIBs)date_rangeTime Frame:Retrospective analysis of data from 1987 to 2016
- Reccurence rate of major GIBsdate_rangeTime Frame:Retrospective analysis of data from 1987 to 2016
- Mortality rate of GIBsdate_rangeTime Frame:Retrospective analysis of data from 1987 to 2016
- Case-fatality rate of GIBsdate_rangeTime Frame:Retrospective analysis of data from 1987 to 2016
- Risk factors of GIBsdate_rangeTime Frame:Retrospective analysis of data from 1987 to 2016
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A