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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-04

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Thrombosis Pulmonary Embolism Enoxaparin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intensive care unit patients

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

Anti-factor Xa activity calibrated for enoxaparin

Intervention Type DIAGNOSTIC_TEST

Anti-factor Xa activity calibrated for enoxaparin

Interventions

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Anti-factor Xa activity calibrated for enoxaparin

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No