Enoxaparin, Pulmonary Embolism, Thrombosis
Conditions
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.
Interventions
DIAGNOSTIC_TESTAnti-factor Xa activity calibrated for enoxaparin
Anti-factor Xa activity calibrated for enoxaparin
Sponsors
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 pulmonary embolism | until discharge from the intensive care unit or up to 14 days after study inclusion | — |
| 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 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 venous thromboembolism | prevalent at study enrolment | — |
| Number of patients with deep vein thrombosis | prevalent at study enrolment | — |
| Number of patients with pulmonary embolism | prevalent at study enrolment | — |
| Number of patients with new-onset venous thromboembolism | 90 days after 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 days with major and/or fatal bleeding | until discharge from the intensive care unit or up to 14 days after study inclusion | — |
| Number of red blood cell concentrates administered | 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 | — |
| Length of stay in the intensive care unit | 90 days after study enrolment | — |
| Length of stay in the hospital | 90 days after study enrolment | — |
| Death | 90 days after study enrolment | — |
| Days alive and out of the intensive care unit | 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) 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. |
| 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. |
Countries
Austria
Contacts
CONTACTChristoph Dibiasi, MD
PRINCIPAL_INVESTIGATOREva Schaden, MD
Medical University of Vienna
Outcome results
None listed