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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive care unit patients | Patients who are admitted to an participating intensive care unit who do not receive therapeutic anticoagulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-factor Xa activity calibrated for enoxaparin | Diagnostic Test | Anti-factor Xa activity calibrated for enoxaparin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | until discharge from the intensive care unit or up to 14 days after study inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitted to an surgical or medical intensive care unit who do not receive therapeutic anticoagulation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christoph Dibiasi, MD | Contact | 0043 1 40400 | 41020 | christoph.dibiasi@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Eva Schaden, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Medical University of Graz | Recruiting | Graz | Styria | 8063 | Austria |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
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| 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 | 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. | 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. | 90 days after study enrolment |
| Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck | Recruiting | Innsbruck | Tyrol | 6020 | Austria |
|
| Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
|
| D012140 |
| Respiratory Tract Diseases |
| D004617 | Embolism |