Clinical trial NCT06357403: Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients
Official title: Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients: a Prospective Multicentre Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thrombosis
Pulmonary Embolism
Enoxaparin
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to an surgical or medical intensive care unit who do not receive therapeutic anticoagulation

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with new-onset venous thromboembolism
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
Secondary outcomes:
measure: Number of patients with new-onset upper extremity deep vein thrombosis
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of patients with new-onset lower extremity deep vein thrombosis
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of patients with new-onset central vein thrombosis
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of patients with new-onset symptomatic upper extremity deep vein thrombosis
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of patients with new-onset symptomatic lower extremity deep vein thrombosis
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of patients with new-onset incidental upper extremity deep vein thrombosis
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of patients with new-onset incidental lower extremity deep vein thrombosis
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of patients with new-onset pulmonary embolism
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of patients with new-onset symptomatic pulmonary embolism
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of patients with new-onset incidental pulmonary embolism
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of patients with venous thromboembolism
timeFrame: prevalent at study enrolment
measure: Number of patients with deep vein thrombosis
timeFrame: prevalent at study enrolment
measure: Number of patients with pulmonary embolism
timeFrame: prevalent at study enrolment
measure: Number of patients with new-onset venous thromboembolism
timeFrame: 90 days after study enrolment
measure: Number of days with any bleeding
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of days with major and/or fatal bleeding
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of red blood cell concentrates administered
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Number of days on which either procoagulant medication, platelet transfusion or fresh frozen plasma was administered
timeFrame: until discharge from the intensive care unit or up to 14 days after study inclusion
measure: Length of stay in the intensive care unit
timeFrame: 90 days after study enrolment
measure: Length of stay in the hospital
timeFrame: 90 days after study enrolment
measure: Death
timeFrame: 90 days after study enrolment
measure: Days alive and out of the intensive care unit
timeFrame: 90 days after study enrolment
measure: Days alive and out of the hospital
timeFrame: 90 days after study enrolment
measure: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) index value
timeFrame: 90 days after study enrolment
measure: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) visual analogue scale
timeFrame: 90 days after study enrolment
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Internal Medicine, Medical University of Graz
state: Styria
city: Vienna
country: Austria
facility: Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Eva Schaden, MD
role: PRINCIPAL_INVESTIGATOR
References: