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Anti-factor Xa Based Venous Thromboembolism Prophylaxis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05221879
Enrollment
75
Registered
2022-02-03
Start date
2019-06-23
Completion date
2021-02-15
Last updated
2022-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dose Adjustment of Enoxaparin in ICU Patients

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

Interventions

OTHERDose 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

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparinUp 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..

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026