An observational study in Thrombosis, Pulmonary Embolism and Enoxaparin, sponsored by Medical University of Vienna. Recruiting at 3 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by Medical University of Vienna · Observational
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:
Adult patients admitted to an surgical or medical intensive care unit who do not receive therapeutic anticoagulation
Exclusion Criteria:
Patients who are admitted to an participating intensive care unit who do not receive therapeutic anticoagulation.
Diagnostic Test: Anti-factor Xa activity calibrated for enoxaparin
Anti-factor Xa activity calibrated for enoxaparin
Number of patients with new-onset venous thromboembolism
New-onset deep vein thrombosis and/or new-onset pulmonary embolism. Both symptomatic and incidental events are included.
Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion
Number of patients with new-onset upper extremity deep vein thrombosis
Time frame: 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
Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion
Number of patients with new-onset central vein thrombosis
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion
Number of patients with new-onset pulmonary embolism
Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion
Number of patients with new-onset symptomatic pulmonary embolism
Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion
Number of patients with new-onset incidental pulmonary embolism
Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion
Number of patients with venous thromboembolism
Time frame: prevalent at study enrolment
Number of patients with deep vein thrombosis
Time frame: prevalent at study enrolment
Number of patients with pulmonary embolism
Time frame: prevalent at study enrolment
Number of patients with new-onset venous thromboembolism
Time frame: 90 days after study enrolment
Number of days with any bleeding
Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion
Number of days with major and/or fatal bleeding
Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion
Number of red blood cell concentrates administered
Time frame: 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
Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion
Length of stay in the intensive care unit
Time frame: 90 days after study enrolment
Length of stay in the hospital
Time frame: 90 days after study enrolment
Death
Time frame: 90 days after study enrolment
Days alive and out of the intensive care unit
Time frame: 90 days after study enrolment
Days alive and out of the hospital
Time frame: 90 days after study enrolment
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) index value
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.
Time frame: 90 days after study enrolment
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) visual analogue scale
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.
Time frame: 90 days after study enrolment
Plan to share: Undecided
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Medical University of Vienna