Examining the link between anti-factor Xa activity and blood clots in critically ill patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to analyze the relationship between anti-factor Xa activity and the occurrence of venous thromboembolism (VTE) in critically ill patients admitted to intensive care units. It will investigate how anti-factor Xa levels correlate with both symptomatic and incidental VTE, as well as the impact of enoxaparin anticoagulation on these levels. Additionally, the study will assess the incidence of VTE, bleeding complications, and how these factors relate to patient-centered outcomes such as mortality and quality of life.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Eva Schaden, MD — Medical University of Vienna
• Study coordinator: Christoph Dibiasi, MD
• Email: christoph.dibiasi@meduniwien.ac.at
• Phone: 0043 1 40400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.