Acute Venous Thromboembolism
Conditions
Brief summary
The primary outcome is the rate of adjudicated clinically relevant bleeding (CRB) events defined as the composite of major bleeding (MB) events and/or clinically relevant non-major bleeding events (CRNMB).
Detailed description
a) adjudicated MB events; b) adjudicated CRNMB events; c) adjudicated recurrent VTE events; d) adjudicated VTE-related deaths; e) all-cause mortality; f) medication adherence; g) incremental cost-effectiveness ratios, including cost per one CRB case prevented, cost per one life year saved and cost per one quality-adjusted life year (QALY) gained; h) impact of verbal consent on patient participation in comparison with participants from sites using written informed consent.
Interventions
Sponsors
Royal College Of Surgeons In Ireland, Royal College Of Surgeons In Ireland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the rate of adjudicated clinically relevant bleeding (CRB) events defined as the composite of major bleeding (MB) events and/or clinically relevant non-major bleeding events (CRNMB). | — |
Secondary
| Measure | Time frame |
|---|---|
| a) adjudicated MB events; b) adjudicated CRNMB events; c) adjudicated recurrent VTE events; d) adjudicated VTE-related deaths; e) all-cause mortality; f) medication adherence; g) incremental cost-effectiveness ratios, including cost per one CRB case prevented, cost per one life year saved and cost per one quality-adjusted life year (QALY) gained; h) impact of verbal consent on patient participation in comparison with participants from sites using written informed consent. | — |
Countries
Ireland
Outcome results
None listed