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 groupLocations
3Department of Internal Medicine, Medical University of Graz8063, GrazStyria, Austria
Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck6020, InnsbruckTyrol, Austria
Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna1090, Vienna Austria
Sponsors and collaborators
Medical University of Vienna
Lead sponsor
Source ClinicalTrials.gov