Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients
- Conditions
- ThrombosisPulmonary EmbolismEnoxaparin
- Interventions
- Diagnostic Test: Anti-factor Xa activity calibrated for enoxaparin
- Registration Number
- NCT06357403
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1300
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intensive care unit patients Anti-factor Xa activity calibrated for enoxaparin Patients who are admitted to an participating intensive care unit who do not receive therapeutic anticoagulation.
- Primary Outcome Measures
Name Time Method Number of patients with new-onset venous thromboembolism 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.
- Secondary Outcome Measures
Name Time Method Number of patients with new-onset symptomatic pulmonary embolism until discharge from the intensive care unit or up to 14 days after study inclusion 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 central vein thrombosis 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 incidental 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 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 days with any bleeding 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 Minimum 0. Maximum 100. A value of 0 indicates the worst possible state of health while a value of 100 indicates the best possible state of health.
Number of red blood cell concentrates administered until discharge from the intensive care unit or up to 14 days after study inclusion Death 90 days after study enrolment European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) index value 90 days after study enrolment Minimum -1.0, Maximum 1.0; An index value of 1.0 indicates the best possible state of health. Index values below 0.0 indicate the worst possible state of health.
Trial Locations
- Locations (2)
Department of Internal Medicine, Medical University of Graz
🇦🇹Graz, Styria, Austria
Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna
🇦🇹Vienna, Austria