NCT06357403

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,300 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombosis
• Pulmonary Embolism
• Enoxaparin

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Anti-factor Xa activity calibrated for enoxaparin	Anti-factor Xa activity calibrated for enoxaparin

Timeline

• Start date: 2024-05-04
• Primary completion: 2027-05-01
• Completion: 2027-08-01
• First posted: 2024-04-10
• Last updated: 2025-09-29

Locations

2 sites across 1 country: Austria