Diagnosing Deep-vein Thrombosis Early in Critically Ill Patients (DETECT) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,800
- 试验地点
- 2
- 主要终点
- 90-day mortality
研究概览
简要总结
The DETECT randomized controlled trial addresses the question of whether surveillance ultrasound in critically ill patients by facilitating DVT detection reduces the incidence of PE and lowers all-cause 90-day mortality. The primary outcome is 90-day all-cause mortality.
详细描述
This is an open-label multicenter multinational randomized-controlled trial. All patients admitted to ICU will be screened within the first 48 hours of ICU admission for eligibility. Subjects who meet all criteria for enrollment will be randomized via a password-protected, secure website using a variable-size block concealed computer-generated randomization procedure. Patients will be allocated to twice weekly bilateral lower limb ultrasound or standard care (control) in a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Medical, surgical or trauma ICU patients ≥18 years old.
- •Patients who are expected to stay in the ICU more than 2 calendar days (unlikely to be discharged out of ICU on the day of admission or on the next day).
排除标准
- •Patients with DVT or PE diagnosed within the last year.
- •Patients receiving chronic systemic anticoagulation.
- •Patients who have received up to the time of ICU admission or are receiving therapeutic doses of anticoagulation with UFH, LMWH, or other anticoagulants.
- •Inability or contraindication to obtain adequate ultrasound on the lower extremities (Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs, large dressings in the thighs that prevent adequate ultrasounds OR amputated foot or leg on one or two sides)
- •Patients with Inferior Vena Cava (IVC) Filter.
- •Known or suspected pregnancy.
- •Limitation of life support, life expectancy <7 days or palliative care.
- •Previously enrolled in DETECT trial within the last 180 days.
- •Enrolled in another trial for which co-enrolment is not approved.
研究组 & 干预措施
Ultrasound Group
Patients will be receiving twice weekly proximal lower limb ultrasound
干预措施: Proximal lower limb ultrasound (Diagnostic Test)
Control Group
Proximal lower limb ultrasound will be performed as per the treating team discretion
结局指标
主要结局
90-day mortality
时间窗: 90 days
Mortality 90 days post randomization
次要结局
- Proximal DVT(From randomization date to day 28 or ICU discharge whichever comes first)
- Pulmonary Embolism(From randomization date and throughout hospital stay up to day 28)
- Clinically important bleeding(From randomization date and throughout hospital stay up to day 90)