ClinicalTrials.Veeva

Menu

Anti-factor Xa Based Venous Thromboembolism Prophylaxis

Clalit Health Services logo

Clalit Health Services

Status

Completed

Conditions

Dose Adjustment of Enoxaparin in ICU Patients

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05221879
MMC-18-0262

Details and patient eligibility

About

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

Enrollment

75 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

75 participants in 2 patient groups

Patients with target factor 10a levels
No Intervention group
Description:
Patients with target factor 10a levels continued to recieve the standard Enoxaparin dose of 40 mg SC daily.
Patients with sub-therapuetic factor 10a levels
Other group
Description:
In patients with sub-therapuetic factor 10a levels we increased the Enoxaparin dose to 60 mg SC daily.
Treatment:
Other: Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems