The Role Of Combined Therapy With Aspirin and Enoxaparin In Prevention Of Venous Thromboembolism In Trauma Patients: A Randomized-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Incidence of Venous Thromboembolism
研究概览
简要总结
The purpose of this study is to determine if the addition of antiplatelet therapy (i.e. aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of venous thromboembolism (VTE) in high-risk critically injured patients. The investigators further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and enoxaparin for decreasing the incidence of VTE after trauma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Age 18 years or older
- •Blunt or penetrating trauma
- •Requires VTE thromboprophylaxis
- •High-risk for VTE
排除标准
- •Presence of VTE upon admission
- •Pregnant or nursing
- •Inability to give informed consent by patient or healthcare proxy
- •Contraindication to enoxaparin
- •Contraindication to aspirin
- •Epidural or subdural hematoma
- •Presence, or removal within the last 12 hours, of an epidural or spinal catheter, or recent (within the last 12 hours) epidural or spinal anesthesia/procedures
研究组 & 干预措施
Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)
Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.
干预措施: Aspirin (Drug)
Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)
Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.
干预措施: Enoxaparin (Drug)
Low Molecular Weight Heparin (LMWH) Alone
Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Incidence of Venous Thromboembolism
时间窗: Up to 2 months of hospitalization
Incidence of VTE is defined as new cases reported of: 1. Deep Vein Thrombosis (DVT), symptomatic or asymptomatic as assessed via venous duplex ultrasonography, and 2. Pulmonary Embolism (PE), symptomatic or asymptomatic as assessed via chest computed tomography with angiography (CTA) or ventilation-perfusion (VQ) Scan
次要结局
- Change in Hypercoagulability(Baseline, up to 2 months hospitalization)
- Mortality(Up to 2 months of hospitalization)
研究者
Kenneth Proctor
Professor of Surgery
University of Miami