NCT01133002已完成不适用
National, Prospective, Observational, Cohort Study of Venous Thromboembolism (VTE) Management With the Low Molecular Weight Heparin, Enoxaparin, in the Outpatient Setting in Canada
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 915
- 试验地点
- 1
- 主要终点
- Proportion of patients with Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE) and/or thrombosis at unusual sites
研究概览
简要总结
Primary Objective:
- To obtain prospective, clinical practice-based data on how symptomatic VTE is managed with low molecular weight heparin (LMWH) enoxaparin in Canadian outpatient settings.
Secondary Objective:
- To describe the demographic and clinical characteristics of patients with symptomatic VTE including characteristics of VTE, VTE risk factors and bleeding risk factors.
- To assess the frequency of patient characteristics that would necessitate adjustment in the dose or duration of enoxaparin therapy, e.g. high BMI, impaired creatinine clearance, advanced age, cancer-associated VTE.
- To assess the degree of adherence in clinical practice to Consensus Guidelines (ACCP/American College of chest Physician 2008) for the management of acute VTE, vis a vis:
- Appropriate dosing of enoxaparin
- Recommended duration of initial LMWH therapy
- Adequate overlap of LMWH with vitamin K antagonists (VKA)
- Recommended duration of longterm VKA
- Frequency of use of LMWH monotherapy to treat cancer-related VTE
- To access safety outcomes (including bleeding and recurrent VTE)
- To describe the utilization of resources due to bleeding and recurrent VTE during the treatment period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of patients with Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE) and/or thrombosis at unusual sites
时间窗: Day 180 or end of anticoagulant therapy whichever comes first
Percentage of exnoxaparin prefilled syringes vs. multidose vials used during treatment
时间窗: Day 180 or end of anticoagulant therapy whichever comes first
Number of patients prescribed twice daily (BID) vs. once daily (QD) enoxaparin
时间窗: Day 180 or end of anticoagulant therapy whichever comes first
Proportion of patients who used short (5-7 days) vs. longer use (more than 7 days) durations of treatment with enoxaparin
时间窗: Day 180 or end of anticoagulant therapy whichever comes first
次要结局
- Incidence of bleeding events and episodes of recurrent VTE(Day 180 or end of anticoagulant therapy whichever comes first)
- Percentage of cases managed as recommended by Concensus Guidelines (ACCP 2008)(Day 180 or end of anticoagulant therapy whichever comes first)
- To tabulate VTE-related resources utilized during the study period and compare resource utilization in patients treated vs not treated as per Concensus Guidelines (ACCP 2008)(Day 180 or end of anticoagulant therapy whichever comes first)
- Patient characteristics associated with different patterns of VTE management and enoxaparin use(Day 180 or end of anticoagulant therapy whichever comes first)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Incidence of Venous Thromboembolism and Professional Practices in Brest AreaVenous ThromboembolismNCT02895971University Hospital, Brest1,416
已完成
不适用
An Observational Study on Incidence, Natural History and Treatment Patterns of Venous Thromboembolism in TaiwanVenous ThromboembolismNCT03799016Bayer104,215
Unknown
不适用
Venous Thromboembolic Complications in Ovarian CancerOvarian NeoplasmsDeep Vein ThrombosisLung EmbolismOvarian CancerVenous ThromboembolismNCT02480790Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery98
已完成
不适用
Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)Osteoporosis, PostmenopausalNCT01416194Pfizer10,497
已完成
不适用
Observational Prospectif Monocentric Registry of Patients Suffering From VIEVenous Thromboembolic DiseaseNCT02188056University Hospital, Strasbourg, France300