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临床试验/NCT04141228
NCT04141228已完成不适用

Evaluation of Hospital Healthcare Utilization and Costs Among Hospitalized Venous Thromboembolism (VTE) Patients Treated With Apixaban or Warfarin in the United States

Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 28,000 人开始时间: 2016年11月29日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28,000
试验地点
1
主要终点
Hospital Length of stay (LOS)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

Hospital Length of stay (LOS)

时间窗: During the index hospitalization (Up to 30 days)

Hospital cost

时间窗: During the index hospitalization (Up to 30 days)

次要结局

  • 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)
  • Mean number of hospital readmissions for combined VTE- or MB-related 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)
  • 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)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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