Anti-factor Xa Based Venous Thromboembolism Prophylaxis

Not Applicable

Completed

• Conditions: Dose Adjustment of Enoxaparin in ICU Patients
• Interventions: Other: Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a

• Registration Number: NCT05221879
• Lead Sponsor: Meir Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-23
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-15
• Status Verified: 2022-01
• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-01-23
• Last Update Submitted: 2022-01-23
• Study First Posted: 2022-02-03
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Patients with sub-therapuetic factor 10a levels	Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a	In patients with sub-therapuetic factor 10a levels we increased the Enoxaparin dose to 60 mg SC daily.

Primary Outcome Measures

Name	Time	Method
Peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin	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..

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel