NCT06357403招募中不适用
Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients: a Prospective Multicentre Cohort Study
适应症
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
- Number of patients with new-onset venous thromboembolism
研究概览
简要总结
The goal of this observational study is to analyse the association between anti-factor Xa activity (antiXa) and the occurence of venous thromboembolism (VTE; either deep vein thrombosis and/or pulmonary embolism) in critically ill patients who are admitted to an intensive care unit. The main questions it aims to answer are:
- What is the association between antiXa and VTE?
- What is the association between antiXa and symptomatic, respectively incidental, VTE?
- How is pharmacological anticoagulation with enoxaparin related to measured antiXa?
- What is the association between antiXa and bleeding complications.
- What is the incidence of venous thromboembolism in patients treated at an intensive care unit?
- How is the occurence of VTE related to patient-centred outcomes such as mortality, quality of life, length of stay and days outside of the intensive care unit/hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 over 18 years at the time of intensive care unit admission
- •Admission to a participating intensive care unit within the last 24 hours
- •Expected discharge is later than 48 hours after enrolment
排除标准
- •Therapeutic anticoagulation, defined as enoxaparin dose of at least 100 IE/kg when given twice daily or of at least 150 IE/kg when given once daily
- •Extracorporeal membrane oxygenation in place or planned within 48 hours of study enrolment
- •Planned regular administration of vitamin K antagonists, unfractionated heparin, low molecular weight heparin other than enoxaparin, thrombin inhibitors or factor X inhibitors within the observation period
- •Estimated life expectancy below 48 hours or comfort terminal care order in place
- •Previously diagnosed heparin-induced thrombocytopenia
- •Pre-operative admission for elective surgery
- •Previous enrolment in the study
结局指标
主要结局
Number of patients with new-onset venous thromboembolism
时间窗: until discharge from the intensive care unit or up to 14 days after study inclusion
New-onset deep vein thrombosis and/or new-onset pulmonary embolism. Both symptomatic and incidental events are included.
次要结局
- Number of patients with new-onset symptomatic pulmonary embolism(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Death(90 days after study enrolment)
- Number of days with major and/or fatal bleeding(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Number of days on which either procoagulant medication, platelet transfusion or fresh frozen plasma was administered(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Number of patients with new-onset incidental lower extremity deep vein thrombosis(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Number of days with any bleeding(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Number of patients with new-onset symptomatic upper extremity deep vein thrombosis(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Number of patients with new-onset incidental upper extremity deep vein thrombosis(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Number of patients with new-onset lower extremity deep vein thrombosis(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Number of patients with new-onset pulmonary embolism(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Number of patients with deep vein thrombosis(prevalent at study enrolment)
- Number of patients with pulmonary embolism(prevalent at study enrolment)
- Number of patients with new-onset central vein thrombosis(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Number of patients with venous thromboembolism(prevalent at study enrolment)
- Length of stay in the intensive care unit(90 days after study enrolment)
- Number of patients with new-onset upper extremity deep vein thrombosis(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Number of patients with new-onset symptomatic lower extremity deep vein thrombosis(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Number of patients with new-onset incidental pulmonary embolism(until discharge from the intensive care unit or up to 14 days after study inclusion)
- Number of patients with new-onset venous thromboembolism(90 days after study enrolment)
- Days alive and out of the intensive care unit(90 days after study enrolment)
- Length of stay in the hospital(90 days after study enrolment)
- Days alive and out of the hospital(90 days after study enrolment)
- European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) visual analogue scale(90 days after study enrolment)
- Number of red blood cell concentrates administered(until discharge from the intensive care unit or up to 14 days after study inclusion)
- European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) index value(90 days after study enrolment)
研究者
Eva Schaden
Assoc. Prof. Dr.
Medical University of Vienna
研究点 (5)
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