Comparison of the Risk of Venous Thromboembolism and Bleeding Events in a Population of Obese Patients Receiving Higher-Dose or Extended-Duration Versus Conventional-Dose or Conventional-Duration of Prophylaxis With Enoxaparin
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 21,000
- 试验地点
- 1
- 主要终点
- Change in the incidence of symptomatic VTE, from index date to Day 90
研究概览
简要总结
In individuals with obesity, the optimal dosing and duration of venous thromboembolism (VTE) prophylaxis in settings representing acute medical illness or surgery is limited due to lack of randomized controlled trials (RCTs) focusing specifically on this population. Evidence suggests that in obese participants, both higher dosing and duration of VTE prophylaxis with Low Molecular Weight Heparins (LMWH) may be required to achieve a therapeutic effect similar to non-obese participants.
This non-interventional study utilizes data already collected from a usual clinical practice setting in the Optum US clinical database, representing obese participants hospitalized with an acute medical condition or undergoing surgery receiving enoxaparin prophylaxis. Its aim is to compare the impact of the following enoxaparin prophylaxis strategies on the incidence of symptomatic VTE and major bleeding in the overall study population and prespecified subgroups:
- High versus conventional dose
- Extended versus conventional duration
- Combined High-Dose and Extended-Duration versus Conventional-Dose and Conventional-Duration.
The first date of enoxaparin prophylaxis will be the index date.
详细描述
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
- •Medical Patients: Hospitalization due to:
- •Heart failure
- •Ischemic stroke
- •Respiratory insufficiency
- •Infection
- •Inflammatory diseases
- •Active cancer
- •Surgical Patents: Following surgery types:
- •Orthopedic
- •Abdominal/Pelvic
- •Other inclusion criteria:
- •Initiation of enoxaparin prophylaxis (index date)
- •Age ≥ 40 years
- •Body Mass Index (BMI) ≥ 30
排除标准
- •VTE or bleeding event during or 3 months prior to index date
- •Surgery within 3 months prior to and up to two days following index date
- •Atrial fibrillation
- •Antiplatelet or anticoagulation therapy within [-32, -2] days before index date
- •Chronic Kidney Disease (CKD) stages IV and V, or dialysis
- •Pregnancy
- •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 symptomatic 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.
The VTE endpoint is intended to represent a new onset symptomatic VTE event. It will be identified in the proposed database by utilizing an algorithm based on the International Classification of Disease 10th and 9th revisions (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.
The 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