Actively Recruiting
Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients: a Prospective Multicentre Cohort Study
Led by Medical University of Vienna · Updated on 2025-09-29
1300
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the relationship between anti-factor Xa activity (antiXa) and the occurrence of venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, in critically ill patients admitted to intensive care units. The study also explores how pharmacological anticoagulation with enoxaparin relates to antiXa levels, the connection between antiXa and bleeding complications, and the impact of VTE on patient outcomes like mortality, quality of life, and hospital stay duration. Participants admitted to intensive care units who do not receive therapeutic anticoagulation will be observed. The study involves measuring anti-factor Xa activity calibrated for enoxaparin and monitoring patients until discharge from the intensive care unit or up to 14 days after enrollment. No experimental treatments or interventions are administered, as this is an observational study. During the study, researchers will track new cases of venous thromboembolism and bleeding events. They will collect data on various types of thrombosis and patient outcomes up to 90 days after enrollment, including length of hospital stay, mortality, and quality of life assessments. The main outcome is the number of patients developing new venous thromboembolism during their intensive care stay or within 14 days after joining the study.
CONDITIONS
Brief Title
Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Receiving therapeutic anticoagulation defined as enoxaparin dose of at least 100 IE/kg twice daily or 150 IE/kg once daily
- Extracorporeal membrane oxygenation in place or planned within 48 hours of study enrolment
- Planned regular use of vitamin K antagonists, unfractionated heparin, low molecular weight heparin other than enoxaparin, thrombin inhibitors or factor X inhibitors during 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 24 hours after intensive care unit admission
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days or until discharge from the intensive care unit
Participants undergo diagnostic testing with anti-factor Xa activity calibrated for enoxaparin to assess blood clotting activity.
Multiple assessments during intensive care unit stay
Duration - Up to 90 days after study enrolment
Participants are monitored for new-onset venous thromboembolism and other health outcomes after initial testing, including up to 90 days post-enrolment.
Follow-up assessments up to 90 days after enrolment
Trial Site Locations
Total: 2 locations
1
Department of Internal Medicine, Medical University of Graz
Graz, Styria, Austria, 8063
Actively Recruiting
2
Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
C
Christoph Dibiasi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here