Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Anti-factor Xa activity calibrated for enoxaparin
Treatment groups
1,300 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov