SToP: Venous Thromboembolism Screening in the Trauma Population
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Asymptomatic lower extremity DVT
研究概览
简要总结
This is a prospective, randomized vanguard trial of trauma patients admitted to the trauma surgery service at Intermountain Medical Center who are deemed to be at high risk for venous thromboembolism. Once identified and enrolled, subjects will be randomized to receive bilateral lower extremity duplex ultrasound surveillance versus no surveillance. The study will compare the two groups with regard to deep vein thrombosis, pulmonary embolism, and major and clinically relevant bleeding episode rates, both during the index hospitalization and at 90 days post-discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Inpatient status on Intermountain Medical Center (IMC) trauma surgery service, admitted within 24 hours of injury.
- •Age ≥18 at the time of injury
- •Meets the definition of high-risk for VTE according to current IMC trauma service guidelines
排除标准
- •Patient age <18 years at the time of admission to the hospital
- •Patients with a life expectancy of less than 30 days
- •Patients with a known hypercoagulable state including:
- •Factor V Leiden
- •Protein C and S deficiencies
- •Dysfibrogenemia of any sort
- •Active cancer
- •Antiphospholipid antibody syndrome
- •History of DVT or PE within past 6 months
- •Myeloproliferative disorders
- •Patients on therapeutic anticoagulation who do not have their agent held upon admission to the hospital.
- •Patient elects to opt-out of the study
研究组 & 干预措施
Surveillance arm
Bilateral duplex ultrasound surveillance
干预措施: Duplex ultrasound surveillance (Other)
No surveillance arm
no duplex ultrasound surveillance
干预措施: No ultrasound surveillance (Other)
结局指标
主要结局
Asymptomatic lower extremity DVT
时间窗: during index hospitalization, up to 2 weeks
any DVT found in the lower extremity
次要结局
- All cause mortality(90 days)
- Symptomatic DVT propagation from calf veins to proximal veins(14 days from hospital discharge)
- Symptomatic/fatal pulmonary embolism(90 days from hospital discharge)
- Major and clinically relevant bleeding episodes(during index hospitalization, up to 2 weeks)
- Composite outcome of proximal DVT plus major and clinically relevant bleeding episodes(during index hospitalization, up to 2 weeks)
- Symptomatic DVT(90 days)