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Anti-factor Xa Based Venous Thromboembolism Prophylaxis

NCT05221879 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-02-03

No results posted yet for this study

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

Conditions

  • Dose Adjustment of Enoxaparin in ICU Patients

Interventions

OTHER

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

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.

Sponsors & Collaborators

  • Meir Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-23
Primary Completion
2021-02-15
Completion
2021-02-15

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05221879 on ClinicalTrials.gov