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

NCT06357403 | Recruiting

• 1 other identifier: AntiXa-ICU 1881/2023
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Thrombosis; Pulmonary Embolism; Enoxaparin

Outcome Measures

Primary Outcomes (1)

• Number of patients with new-onset venous thromboembolism

  New-onset deep vein thrombosis and/or new-onset pulmonary embolism. Both symptomatic and incidental events are included.

  until discharge from the intensive care unit or up to 14 days after study inclusion

Secondary Outcomes (25)

• Number of patients with new-onset upper extremity deep vein thrombosis

  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

  until discharge from the intensive care unit or up to 14 days after study inclusion

• Number of patients with new-onset central vein thrombosis

  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

  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

  until discharge from the intensive care unit or up to 14 days after study inclusion

Study Arms (1)

Intensive care unit patients

Patients who are admitted to an participating intensive care unit who do not receive therapeutic anticoagulation.

Diagnostic Test: Anti-factor Xa activity calibrated for enoxaparin

Interventions

Anti-factor Xa activity calibrated for enoxaparin DIAGNOSTIC_TEST

Anti-factor Xa activity calibrated for enoxaparin

Intensive care unit patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to an surgical or medical intensive care unit who do not receive therapeutic anticoagulation

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (2)

Department of Internal Medicine, Medical University of Graz

Graz, Styria, 8063, Austria

RECRUITING

Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Eva Schaden, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Dibiasi, MD

CONTACT

0043 1 40400; christoph.dibiasi@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: April 10, 2024
• Study Start: May 4, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

AU (2)