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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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Thrombosis
    Pulmonary Embolism
    Enoxaparin

NCT06357403

Medical University of Vienna

29 May 2024

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