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

Pulmonary Embolism Clinical Trial

— AntiXa-ICU  

Official title:

Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients: a Prospective Multicentre Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06357403
• Other study ID #: AntiXa-ICU 1881/2023
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: Medical University of Vienna
• Contact: Christoph Dibiasi, MD
• Phone: 0043 1 40400
• Email: christoph.dibiasi[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1300
• Est. completion date: August 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Enoxaparin
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism

Intervention

Diagnostic Test:
• Anti-factor Xa activity calibrated for enoxaparin
Anti-factor Xa activity calibrated for enoxaparin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	Number of patients with new-onset central vein thrombosis		until discharge from the intensive care unit or up to 14 days after study inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients with new-onset pulmonary embolism		until discharge from the intensive care unit or up to 14 days after study inclusion
Secondary	Number of patients with new-onset symptomatic pulmonary embolism		until discharge from the intensive care unit or up to 14 days after study inclusion
Secondary	Number of patients with new-onset incidental pulmonary embolism		until discharge from the intensive care unit or up to 14 days after study inclusion
Secondary	Number of patients with venous thromboembolism		prevalent at study enrolment
Secondary	Number of patients with deep vein thrombosis		prevalent at study enrolment
Secondary	Number of patients with pulmonary embolism		prevalent at study enrolment
Secondary	Number of patients with new-onset venous thromboembolism		90 days after study enrolment
Secondary	Number of days with any bleeding		until discharge from the intensive care unit or up to 14 days after study inclusion
Secondary	Number of days with major and/or fatal bleeding		until discharge from the intensive care unit or up to 14 days after study inclusion
Secondary	Number of red blood cell concentrates administered		until discharge from the intensive care unit or up to 14 days after study inclusion
Secondary	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
Secondary	Length of stay in the intensive care unit		90 days after study enrolment
Secondary	Length of stay in the hospital		90 days after study enrolment
Secondary	Death		90 days after study enrolment
Secondary	Days alive and out of the intensive care unit		90 days after study enrolment
Secondary	Days alive and out of the hospital		90 days after study enrolment
Secondary	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
Secondary	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