Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients

Medical University of Vienna1,300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,300

Conditions

Thrombosis Pulmonary Embolism Enoxaparin

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Department of Internal Medicine, Medical University of Graz

Graz, Styria, Austria

RECRUITING

Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna

Vienna, Austria

RECRUITING

Outcomes

Primary Outcomes

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 inclusion

Secondary Outcomes

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 inclusion

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 inclusion

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 inclusion

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 inclusion

Number of patients with new-onset symptomatic lower extremity deep vein thrombosis

Time frame: 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

Time frame: 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

Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion

Number of patients with new-onset pulmonary embolism

Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion

Number of patients with new-onset symptomatic pulmonary embolism

Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion

Number of patients with new-onset incidental pulmonary embolism

Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion

Number of patients with venous thromboembolism

Time frame: prevalent at study enrolment

Number of patients with deep vein thrombosis

Time frame: prevalent at study enrolment

Number of patients with pulmonary embolism

Time frame: prevalent at study enrolment

Number of patients with new-onset venous thromboembolism

Time frame: 90 days after study enrolment

Number of days with any bleeding

Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion

Number of days with major and/or fatal bleeding

Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion

Number of red blood cell concentrates administered

Time frame: 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

Time frame: until discharge from the intensive care unit or up to 14 days after study inclusion

Length of stay in the intensive care unit

Time frame: 90 days after study enrolment

Length of stay in the hospital

Time frame: 90 days after study enrolment

Death

Time frame: 90 days after study enrolment

Days alive and out of the intensive care unit

Time frame: 90 days after study enrolment

Days alive and out of the hospital

Time frame: 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.

Time frame: 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.

Time frame: 90 days after study enrolment

Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts