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临床试验/NCT05028244
NCT05028244已完成不适用

Systematic Ultrasound Screening for Lower Extremity Deep Vein Thrombosis in ICU Patients With Severe COVID-19: a Randomized Clinical Trial.

Hospital Universitari Vall d'Hebron Research Institute1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2021年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
1
主要终点
Mortality

研究概览

简要总结

This clinical trial is designed to evaluate if the periodic screening for deep venous thrombosis by ultrasound of lower extremity in patients with intensive care unit (ICU) patients with COVID 19 impacts on mortality, ICU stay and total length of stay in the hospital, along with other outcomes.

详细描述

Background: COVID-19 has a high incidence of venous thromboembolic disease (VTE), especially pulmonary thromboembolism (PE) and deep vein thrombosis (DVT), with an even higher incidence in patients admitted to the intensive care unit (ICU). The presentation of these events is related to an increase in mortality and the mean stay in the ICU. The impact of systematic screening for asymptomatic lower extremity DVT in these patients has not been studied, so we propose to carry out a clinical trial to assess its impact in these patients.

Hypothesis

Serial DVT screening in patients admitted to the ICU for COVID-19 does not improve survival, mean stay, or the incidence of symptomatic VTE.

Objective

To study whether DVT screening in these patients has an impact on the incidence of symptomatic VTE, mortality and average stay in the ICU.

Methods: Non-blind randomized clinical trial on all patients aged 18 years or older admitted to the ICU for COVID-19 with less than 72 hours elapsed since their admission to the unit. Patients with DVT or PE will be excluded at the time of recruitment (all patients will be ruled out by routine ultrasound and computed tomography angiography (CT Angiography)); Pregnant patients, patients with a previous diagnosis of DVT or PE, and patients undergoing extracorporeal membrane oxygenation (ECMO) will also be excluded. Patients will be randomized into two arms at the time of inclusion: the screened group (Group 1) and the non-screened group (Group 2). Group 1: patients who will be treated according to the usual ICU protocol and, additionally, will undergo serial ultrasounds of the lower extremities twice a week (Monday and Thursday). Group 2: they will be treated according to the usual ICU protocol and no screening examinations will be performed. Patients will be followed until discharge from the ICU or death and up to a maximum of 3 weeks. The incidence of symptomatic VTE will be assessed, as well as all-cause mortality and days of stay in the ICU. Clinical and laboratory variables will be collected from each patient for subsequent statistical analysis.

Relevance: The thrombotic complications of COVID-19 are well described, as well as their high incidence in critically ill patients. This work aims to clarify the current doubts about the need for systematic DVT screening in these patients. If our hypothesis is verified, a limited resource such as ultrasound of the lower limbs could be saved, as well as the use of the necessary protection materials and, most importantly, avoid unnecessary exposure of health personnel with the consequent risk that it represents for other professionals and patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • •COVID 19 patients in their first 72 hours of entering ICU

排除标准

  • •Pregnant patients
  • •Not COVID 19 confirmed patients by RCP
  • •Patients that are in Extracorporeal membrane oxygenation
  • •Patients with previous thrombotic disease

研究组 & 干预措施

Intervention group

Experimental

Selected patients undergo lower extremity ultrasound for diagnosis of deep vein thrombosis 2 times per week (Mondays and Thursdays) in a period of 3 weeks (21 days) of follow up

干预措施: venous ultrasound of lower extremity (Diagnostic Test)

control group

No Intervention

This group only undergo the first ultrasound assessment to discard previous thrombosis not detected during hospitalisation or ambulatory

结局指标

主要结局

Mortality

时间窗: 21 days

Patients that die in ICU during follow up

Symptomatic deep venous thrombosis

时间窗: 21 days

presence of confirmed deep vein thrombosis and presence of symptoms

ICU Stay

时间窗: 21 days

Number of days staying in that unit during follow up

次要结局

  • composite outcome(21 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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