Anti-factor Xa Based Venous Thromboembolism Prophylaxis

Study Overview
=================
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

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

Conditions
-----------------
Dose Adjustment of Enoxaparin in ICU Patients

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


Participation Criteria
=================
Eligibility 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. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Patients with target factor 10a levels<br>Patients with target factor 10a levels continued to recieve the standard Enoxaparin dose of 40 mg SC daily. | |
| Other: Patients with sub-therapuetic factor 10a levels<br>In patients with sub-therapuetic factor 10a levels we increased the Enoxaparin dose to 60 mg SC daily. | Other: Dose adjustment of Enoxaparin in patients with sub-therapuetic (prophylactic) levels of factor 10a<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin | We measured peak aFXa levels following 2 consecutive doses of sc 40 mg enoxaparin among ICU patients who recieved enoxaparin for VTE prophylaxis.. | Up to 72 hours from ICU admission. |