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Completed

NCT Number: NCT05221879

Anti-factor Xa Based Venous Thromboembolism Prophylaxis

Introduction: Venous thromboembolism (VTE) in the intensive care unit (ICU) is associated with significant morbidity and mortality therefore prevention is imperative to reduce its burden. VTE prophylaxis in ICU patients is primarily pharmacological using low molecular weight heparin. This study aims to determine the proportion of ICU patients receiving VTE prophylaxis that achieves appropriate anti-factor Xa activity (aFXa) prophylactic levels and to characterize this patient population Methods: Seventy-five patients admitted to the General ICU were included. Peak and trough aFXa levels were measured at 4 and 23 hours respectively after receiving the second consecutive daily enoxaparin 40 mg sc injection. Patients in whom peak aFXa levels were found to be sub-prophylactic, peak and trough levels were repeated as above

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Key information

Conditions

Dose Adjustment of Enoxaparin in ICU Patients

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meir Medical Center

Kfar Saba, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria were age over 18 years and a predicted ICU stay of more than 72 h.

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Exclusion criteria

Exclusion criteria were any contraindication for heparin-based thromboembolic prophylaxis, patients with an indication for therapeutic anticoagulation , administration of unfractioned-heparin or low-molecular-weight-heparin prior to study entry, active hemorrhage, or creatinine clearance < 30 mL/min.

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Treatment and study plan

Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a

Other

We screened ICU patients who recieved DVT prophylaxis with fixed dose of Enoxaparin (40 mg SC daily) for peak blood levels of factor 10A. For patients who did not achieve therapuetic 10a levels (0.2-0.4) we increased the Enoxaparin dose to 60 mg SC daily.

Primary outcomes

  1. Peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin

    Time frame: Up to 72 hours from ICU admission.

    We measured peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin among ICU patients who recieved enoxaparin for VTE prophylaxis..

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

Anti-factor Xa Based Venous Thromboembolism Prophylaxis: Dose Adjustment in ICU Patients

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2022
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.