A Comparison of Extended Versus Conventional Duration of Enoxaparin Prophylaxis for VTE and Bleeding Event Risk in a Population With Acute Medical Illness
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 14,799
- 试验地点
- 1
- 主要终点
- Change in the incidence of VTE, from index date to Day 90
研究概览
简要总结
Venous Thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is associated with an increase in risk of mortality and long-term disability and is a major contributor to global disease burden. Participants hospitalized with an acute medical illness are at increased risk of VTE.
This study a non-interventional study which analyzes data already collected in the Optum US clinical database. Its aim is to compare conventional versus extended duration prophylaxis with enoxaparin on the incidence of VTE and bleeding events in participants hospitalized for acute medical illness. The first date of enoxaparin treatment will be the index date.
详细描述
The study population will be developed from the Optum Clinical database in the United States, representing routine clinical practice. Study population will comprise of participants hospitalized for an acute medical illness receiving enoxaparin during hospitalization. The first date of enoxaparin treatment will be the index date. The study period will be from February 2010 to September 2021. Participants will be followed for 90 days.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalization for the following acute conditions:
- •Infection
- •Respiratory insufficiency
- •Inflammatory condition
- •Heart failure
- •Ischemic stroke
- •Initiation of enoxaparin prophylaxis during hospitalization (index date)
- •Age ≥40 years
排除标准
- •Symptomatic VTE or major bleeding event 90-days prior to index date
- •Major surgery within (+1,-90) days from index date
- •Ongoing anticoagulation therapy (medication supply within [-2,-32] days from index date)
- •Atrial fibrillation
- •Chronic kidney disease (CKD) stages IV and V, or dialysis
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
结局指标
主要结局
Change in the incidence of VTE, from index date to Day 90
时间窗: Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.
VTE event will be identified via an algorithm based on the International Classification of Disease-10th revision and 9th revision (ICD-10 and ICD-9) codes.
Change in the incidence of major bleeding, from index date to Day 90
时间窗: Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.
Major bleeding event will be identified via an algorithm based on the International Classification of Disease-10th revision and 9th revision (ICD-10 and ICD-9) codes.
次要结局
未报告次要终点