Ultrasound Screening for Asymptomatic Deep Vein Thrombosis in Critically Ill Patient: a Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,300
- 试验地点
- 5
- 主要终点
- Proximal deep vein thrombosis
研究概览
简要总结
Background: venous thromboembolism (VTE) is a common complication in critically ill patients, admitted to the Intensive Care Units (ICUs). At the present time, there is no validated score to estimate risks and benefits of antithrombotic pharmacological prophylaxis in this subset of patients. Results of a pilot study showed that ultrasound (US) screening for deep vein thrombosis (DVT) is associated with a reduced incidence of proximal DVT, up front to an overall increased discovery rate of DVTs. The reduced incidence of proximal DVT could be attributed to an early diagnosis of distal and muscular DVTs, which would eventually receive a more adequate management. Proximal DVTs are associated with a worse long-term prognosis than distal or muscular DVTs, so it can be hypothesized that the active US screening could lead to an improvement of in-hospital and long-term prognosis of patients admitted to the ICU.
Aim of the study: to test whether an active US screening may reduce the incidence of proximal DVT and improve the in-hospital and long-term prognosis of patients admitted to the ICU.
Expected relevance: systematic screening for DVT could improve the management of the pharmacological antithrombotic treatment, leading to a reduction of thromboembolic and bleeding complications. This will eventually lead to an improved in-hospital and long-term prognosis.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Enrolling centers are blinded to each others. Investigators are blinded to centers allocation.
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
- •any patient admitted to ICU with a length-of-stay in ICU >96 hours
排除标准
- •pregnancy
- •SARS-CoV-2 infection
- •established DVT or pulmonary embolism at admission
- •established coagulation disorder
- •presence of inferior vena cava filter at the admission
- •admission from the ICU of another hospital
研究组 & 干预措施
Screening
Patients will receive an ultrasound screening for DVT between 48 to 96 hours after the admission to the intensive care. In case of negative ultrasound:
- if the pharmacological thromboprophylaxis is NOT possible, ultrasound is repeated after 48-96 hours;
- if the pharmacological thromboprophylaxis is possible, re-evaluation is warrant only in case of clinical changes.
In case of positive ultrasound:
- if the DVT is proximal, it must be treated according to guidelines. Re-evaluation is warranted only in case of clinical changes;
- if the DVT is distal and a full or intermediate anti-thrombotic treatment is possible, re-evaluation is warrant only in case of clinical changes;
- if the DVT is distal and a full or intermediate anti-thrombotic treatment is NOT possible, the ultrasound is repeated after 48-96 hours.
干预措施: Ultrasound screening for lower limbs DVT (Diagnostic Test)
Standard-of-care
Ultrasound examination are performed according to clinical risk of DVT
干预措施: Standard-of-care (Diagnostic Test)
结局指标
主要结局
Proximal deep vein thrombosis
时间窗: Within 48-72 hours after admission to ICU
Deep vein thrombosis located above the popliteal area
次要结局
- Mortality in ICU(From admission to ICU until the date of death from any cause or transfer to other facility, assessed up to 30 days)
- In-hospital mortality(From admission to ICU until the date of death from any cause or discharge, assessed up to 30 days)
- 90-day mortality(Within 90 days after the admission of the ICU)
研究者
Stefano Ministrini
Researcher
University Of Perugia