Potential Harms and Benefits of Systematic Screening for Deep Vein Thrombosis in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of 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.
Aim of the study: investigating potential harms and benefits of a protocol for systematic screening of DVT in critically ill patients, admitted to an ICU.
Expected relevance: systematic screening for deep vein thrombosis (DVT) through ultrasound (US) lower limb veins examination could help defining the indication to antithrombotic pharmacological treatment, but no protocol of systematic screening has been validated so far. Furthermore, the screening could be associated with over-diagnosis and consequent over-treatment, as well as increased management burden for the caregivers and higher healthcare costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age >18 years old
- •Admission to the ICU
排除标准
- •duration of stay in ICU <5 days
- •SARS-CoV-2 infection
- •established DVT or pulmonary embolism at admission
- •established coagulation disorder
- •presence of inferior vena cava filter at the admission
- •admission/discharge to the ICU of another hospital
研究组 & 干预措施
Screening
Ultrasound (US) examination of lower limbs 48 hours after admission and again after 3-5 days (5-7 days after the admission)
干预措施: Ultrasound examination of lower limb veins (Diagnostic Test)
Control
Ultrasound (US) examination according to the clinical evaluation of risk factors for deep vein thrombosis (DVT) and life-threatening bleeding, based on the standard of care (SOC) of the enrolling institution.
结局指标
主要结局
Incidence of deep vein thrombosis
时间窗: hospitalization in UTI, an average of 10 days
Diagnosis of deep vein thrombosis
次要结局
- Duration of ICU stay(hospitalization in UTI, an average of 10 days)
- Progression of deep vein thrombosis (DVT)(hospitalization in UTI, an average of 10 days)
- Incidence of pulmonary embolism(hospitalization in UTI, an average of 10 days)
- Prophylaxis/ treatment of venous thromboembolism (VTE)(hospitalization in UTI, an average of 10 days)
- Occurrence of anemia(hospitalization in UTI, an average of 10 days)
- Occurrence of major bleeding(hospitalization in UTI, an average of 10 days)
- Risk of new hospital admission within 3 months after hospital discharge(Within 3 months after hospital discharge)
- Risk of death in ICU(hospitalization in UTI, an average of 10 days)
- Risk of death within 3 months after hospital discharge(Within 3 months after hospital discharge)
研究者
Ettore Marini
Principal Investigator
University Of Perugia