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
This trial does not accept healthy volunteersQualifiers
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 population
Adult patients admitted to an surgical or medical intensive care unit who do not receive therapeutic anticoagulation
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Anti-factor Xa activity calibrated for enoxaparin
Diagnostic testAnti-factor Xa activity calibrated for enoxaparin
Treatment groups
1,300 Participants
are divided into 1 treatment groupGroup A: Intensive care unit patients1 intervention
Trial outcomes
Primary outcomes
1
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 inclusionSecondary outcomes
1
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 inclusion2
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 inclusion3
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 inclusion4
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 inclusionSponsors and contacts
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Source ClinicalTrials.gov