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

NCT06357403 · tracked via the Priya Life Science Austria tracker

Sponsor

Medical University of Vienna

Phase

Observational

Started

2024-05-04

Last updated

2026-06-23

Condition(s) studied

ThrombosisPulmonary EmbolismEnoxaparin

Investigational drug(s) / intervention(s)

Anti-factor Xa activity calibrated for enoxaparin

Anti-factor Xa activity calibrated for enoxaparin: Anti-factor Xa activity calibrated for enoxaparin

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

Number of patients with new-onset venous thromboembolism — until discharge from the intensive care unit or up to 14 days after study inclusion
New-onset deep vein thrombosis and/or new-onset pulmonary embolism. Both symptomatic and incidental events are included.

Trial sites (3)

Facility	City	Region	Status
Department of Internal Medicine, Medical University of Graz	Graz	Styria	Recruiting
Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck	Innsbruck	Tyrol	Recruiting
Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna	Vienna	Austria	Recruiting

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Other trials for the same condition

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism Active, not recruiting

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System Recruiting

Pulmonary Embolism International THrOmbolysis Study-3 Active, not recruiting

PUlmonary REhabilitation in Patients Suffering From Post-PE Syndrome Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06357403 on ClinicalTrials.gov ↗ ← All trials in Austria