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Recruiting NCT06357403

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

— Observational Thrombosis Pulmonary Embolism Enoxaparin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anti-factor Xa activity calibrated for enoxaparin.
Who it may be relevant to
Registry conditions: Thrombosis, Pulmonary Embolism, Enoxaparin. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • Diagnostic test Anti-factor Xa activity calibrated for enoxaparin
    Anti-factor Xa activity calibrated for enoxaparin

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • Number of patients with venous thromboembolism [Time frame: prevalent at study enrolment]
  • Number of patients with deep vein thrombosis [Time frame: prevalent at study enrolment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 3 centers
  • Department of Internal Medicine, Medical University of Graz — Graz
  • Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medica — Innsbruck
  • Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University o — Vienna

Identifiers

NCT: NCT06357403 · AntiXa-ICU 1881/2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗