Examining the link between anti-factor Xa activity and blood clots in critically ill patients
Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients: a Prospective Multicentre Cohort Study
This study looks at how a specific blood-thinning activity relates to blood clots in critically ill patients in the ICU to see if it affects their health and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 2 sites (Graz, Styria and 1 other locations) |
| Trial ID | NCT06357403 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are critically ill patients over 18 years old who have been admitted to an intensive care unit within the last 24 hours.
Not a fit: Patients who are already receiving therapeutic anticoagulation or have a life expectancy of less than 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of anticoagulation management in critically ill patients, potentially leading to better prevention strategies for venous thromboembolism.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have explored the relationship between anticoagulation and VTE, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Graz, Styria and 1 other locations
- Department of Internal Medicine, Medical University of Graz — Graz, Styria, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.