Study of the Risk Factors and Outcomes After Gastrointestinal Bleeding
Study Details
Study Description
Brief Summary
The purpose of this multicenter, two component observational and standardized case-control study is to evaluate risk factors of gastrointestinal (GI) bleeding with a prospective 3-month and 12-month follow-up to examine outcomes and their possible causes.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
Antithrombotic therapies are effective for prevention of cardiovascular (CV) events but cause bleeding. Emerging evidence indicates that extra-cranial bleeding is just as important as myocardial infarction as a marker of risk for subsequent non-fatal and fatal CV events, but this issue has not been prospectively studied. If the association between bleeding and CV events is causal, prevention of bleeding, by targeting the risk factors, and prevention of the complications of bleeding, by targeting the causal pathways, could substantially reduce the burden of bleeding-related CV events. Progress in developing these approaches has been limited by a knowledge gap. Known risk factors do not fully explain bleeding risk and the investigators do not understand the mechanisms linking bleeding with adverse outcome and whether the association is causal.
One-half of bleeds that lead to CV events in patients receiving antithrombotic therapy arise in the GI tract. INTERBLEED plans to explore risk factors for GI bleeding, and outcomes after GI bleeding, in this well-circumscribed and important group using a case-control design with prospective 3 month and 12 month follow-up.
Specific objectives are to: (1) identify risk factors for GI bleeding and estimate their population attributable risk; (2) determine the risk of non-fatal and fatal CV events and functional outcomes after GI bleeding; and (3) explore the possible mechanisms linking GI bleeding with CV outcome.
INTERBLEED will recruit 2500 case-control pairs from centres in Argentina, Belgium, Brazil, China, Ireland and the Netherlands. Data will be collected on patient characteristics, medical history and, in cases, the work-up, management and outcomes after bleeding. The INTERBLEED results will help to develop new approaches to reducing the burden of bleeding-related CV events.
Study Design
Outcome Measures
Primary Outcome Measures
- Myocardial infarction, stroke or death [Up to one year]
Secondary Outcome Measures
- Change in functional status from baseline to 3 months [3 months]
Functional status measured by SAGE questionnaire
- Change in functional status from baseline to 12 months [12 months]
Functional status measured by SAGE questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
Cases
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Age ≥ 18 years at enrollment
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Written informed consent
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Confirmed cardiovascular disease
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Present to the hospital with GI tract bleed or develop GI tract bleed in hospital
Controls
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Age ≥ 18 years at enrollment
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Written informed consent
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Confirmed cardiovascular disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hamilton Health Sciences, PHRI | Hamilton | Ontario | Canada |
Sponsors and Collaborators
- Population Health Research Institute
- Heart and Stroke Foundation of Ontario
- Bristol-Myers Squibb
- Daiichi Sankyo, Inc.
Investigators
- Principal Investigator: John Eikelboom, MD, Population Health Research Institute, McMaster University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INTERBLEED