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NCT Number: NCT06357403

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

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.

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism Embolism and Thrombosis Enoxaparin Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal Medicine, Medical University of Graz, Graz, Styria, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-factor Xa activity calibrated for enoxaparin

Diagnostic Test

Anti-factor Xa activity calibrated for enoxaparin

Primary outcomes

  1. Number of patients with new-onset venous thromboembolism

    Time frame: 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. Number of patients with venous thromboembolism

    Time frame: prevalent at study enrolment

  12. Number of patients with deep vein thrombosis

    Time frame: prevalent at study enrolment

  13. Number of patients with pulmonary embolism

    Time frame: prevalent at study enrolment

  14. Number of patients with new-onset venous thromboembolism

    Time frame: 90 days after study enrolment

  15. Number of days with any bleeding

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

  16. 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

  17. Number of red blood cell concentrates administered

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

  18. 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

  19. Length of stay in the intensive care unit

    Time frame: 90 days after study enrolment

  20. Length of stay in the hospital

    Time frame: 90 days after study enrolment

  21. Death

    Time frame: 90 days after study enrolment

  22. Days alive and out of the intensive care unit

    Time frame: 90 days after study enrolment

  23. Days alive and out of the hospital

    Time frame: 90 days after study enrolment

  24. European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) index value

    Time frame: 90 days after study enrolment

    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.

  25. European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) visual analogue scale

    Time frame: 90 days after study enrolment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christoph Dibiasi, MD

CONTACT

[email protected]

0043 1 40400 ext. 41020

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: AntiXa-ICU

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 10, 2024
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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