A Study of Hospital Healthcare Use and Cost in Patients in the Hospital With a Venous Thromboembolism (VTE) Treated With Apixaban or Warfarin in the US
Completed
- Conditions
- Venous Thromboembolism (VTE)
- Registration Number
- NCT04141228
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
A study involving real-world database analysis to evaluate the hospital healthcare utilization and costs, and all-cause, major bleeding-, clinically relevant bleeding-, any bleeding-, and venous thromboembolism (VTE)-related hospital readmissions among hospitalized VTE patients treated with apixaban or warfarin, with or without low molecular weight heparin (LMWH)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28000
Inclusion Criteria
- Have a primary diagnosis of VTE identified by ICD-9-CM or ICD-10 codes from the Premier Hospital database between 01-Aug-2014 and 31-May-2016
- Age 18 years or older as of index hospitalization with VTE diagnosis
- Patients will be required to have received apixaban or warfarin with or without LMWH (index drugs) during the index hospitalizations
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Exclusion Criteria
- Received both apixaban and warfarin during the index hospitalization. This exclusion criterion will allow to cleanly group patients into the apixaban and warfarin usage cohorts.
- Received any other Direct oral anticoagulants (DOAC) including rivaroxaban, dabigatran, and edoxaban during the index hospitalization
- Have any primary or secondary diagnosis code for Atrial fibrillation/Atrial flutter (AF/AFL), or pregnancy, or records of inferior vena cava filter (IVCF) usage during the index hospitalizations or the baseline periods.
- Patients transferred from other facilities
Other protocol-defined inclusion/exclusion criteria could apply
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hospital Length of stay (LOS) During the index hospitalization (Up to 30 days) Hospital cost During the index hospitalization (Up to 30 days)
- Secondary Outcome Measures
Name Time Method Proportion of patients with major bleeding (MB)-related hospital readmissions During 1 month after the index hospitalization Proportion of patients with any bleeding-related hospital readmissions During 1 month after the index hospitalization Proportion of patients with VTE-related hospital readmissions During 1 month after the index hospitalization Hospital LOS for clinically relevant bleeding-related hospital readmissions During 1 month following the VTE hospitalization Mean number of hospital readmissions for clinically relevant bleeding-related hospital readmissions During 1 month following the VTE hospitalization Hospital costs of readmissions for any bleeding-related hospital readmissions During 1 month following the VTE hospitalization Hospital charges of readmissions for combined VTE- or MB-related hospital readmissions During 1 month following the VTE hospitalization Hospital charges of readmissions for all-cause hospital readmissions During 1 month following the VTE hospitalization Proportion of patients with all-cause hospital readmissions During 1 month after the index hospitalization Hospital Length of stay (LOS) for major bleeding-related hospital readmissions During 1 month following the VTE hospitalization Hospital charges of readmissions for major bleeding-related hospital readmissions During 1 month following the VTE hospitalization] Mean number of hospital readmissions for any bleeding-related hospital readmissions During 1 month following the VTE hospitalization Mean number of hospital readmissions for all-cause hospital readmissions During 1 month following the VTE hospitalization Hospital costs of readmissions for major bleeding-related hospital readmissions During 1 month following the VTE hospitalization Mean number of hospital readmissions for VTE-related hospital readmissions During 1 month following the VTE hospitalization Hospital LOS for combined VTE- or MB-related hospital readmissions During 1 month following the VTE hospitalization Proportion of patients with combined VTE- or MB-related hospital readmissions During 1 month after the index hospitalization Proportion of patients with clinically relevant bleeding (CRB)-related hospital readmissions During 1 month after the index hospitalization Mean number of hospital readmissions for major bleeding-related hospital readmissions During 1 month following the VTE hospitalization Hospital costs of readmissions for clinically relevant bleeding-related hospital readmissions During 1 month following the VTE hospitalization Hospital charges of readmissions for clinically relevant bleeding-related hospital readmissions During 1 month following the VTE hospitalization Hospital LOS for any bleeding-related hospital readmissions During 1 month following the VTE hospitalization Hospital charges of readmissions for any bleeding-related hospital readmissions During 1 month following the VTE hospitalization Mean number of hospital readmissions for combined VTE- or MB-related hospital readmissions During 1 month following the VTE hospitalization Hospital LOS for VTE-related hospital readmissions During 1 month following the VTE hospitalization Hospital costs of readmissions for VTE-related hospital readmissions During 1 month following the VTE hospitalization Hospital charges of readmissions for VTE-related hospital readmissions During 1 month following the VTE hospitalization Hospital costs of readmissions for combined VTE- or MB-related hospital readmissions During 1 month following the VTE hospitalization Hospital LOS for all-cause hospital readmissions During 1 month following the VTE hospitalization Hospital costs of readmissions for all-cause hospital readmissions During 1 month following the VTE hospitalization
Trial Locations
- Locations (1)
Local Institution
🇺🇸Flemington, New Jersey, United States