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Rapid Point-of-Care Assay of Enoxaparin Anticoagulant Efficacy in Whole Blood
Published on: October 12, 2012
Evaluation of a Pediatric Enoxaparin Dosing Protocol and the Impact on Clinical Outcomes
Kayla Wiltrout1, Jennifer Lissick1, Mike Raschka1
1Department of Pharmacy (KW, JL, MR), Children's Minnesota, Minneapolis, MN.
Insights
Pediatric enoxaparin dosing needs adjustment. Current protocols achieve therapeutic anti-factor Xa (anti-Xa) levels only 55.8% of the time, impacting thrombus resolution. More aggressive dosing is recommended for better outcomes.
Area of Science:
- Pediatric pharmacology
- Thromboembolism treatment
- Pharmacokinetics
Background:
- Enoxaparin is used for pediatric thromboembolism, but optimal dosing remains debated.
- Current dosing guidelines may be too conservative, limiting efficacy in younger children.
- Limited data exists on escalated enoxaparin doses in pediatric patients.
Purpose of the Study:
- Identify patient factors associated with anti-factor Xa (anti-Xa) levels.
- Determine the relationship between initial anti-Xa levels and thrombus resolution.
- Assess bleeding risks associated with enoxaparin therapy.
Main Methods:
- Retrospective cohort study of 283 pediatric patients (≤18 years).
- Patients received therapeutic subcutaneous enoxaparin for incident thrombus.
- Data collected from October 2008 to October 2018.
Main Results:
- Therapeutic anti-Xa levels achieved on initial lab evaluation correlated with successful thrombus resolution.
- Age, BMI, and specific diagnoses were associated with initial anti-Xa values.
- Bleeding rates were similar across different anti-Xa concentrations.
Conclusions:
- The current enoxaparin dosing nomogram achieves therapeutic anti-Xa levels in only 55.8% of pediatric patients.
- Delayed achievement of therapeutic anti-Xa levels negatively impacts thrombus resolution.
- A more aggressive enoxaparin dosing strategy is necessary for improved clinical outcomes in children.
Objectives:
Enoxaparin has been studied for prophylaxis and treatment of thromboembolism in the pediatric population. Dose-finding studies have suggested higher mean maintenance dose requirements in younger children; however, the current recommended dosing schema endorsed by the American College of Chest Physicians remains conservative, likely secondary to limited data on the safety and efficacy of escalated starting doses. Primary objectives of this study included the identification of patient characteristics and risk factors with associations to anti-factor Xa (anti-Xa) values. The secondary objective was to determine an association between the initial anti-Xa value and thrombus resolution. Safety outcomes related to bleeding were also assessed.
Methods:
This retrospective cohort study reviewed records of all pediatric patients ≤18 years of age who were initiated on therapeutic subcutaneous enoxaparin between October 1, 2008, and October 1, 2018, at Children's Hospitals and Clinics of Minnesota for an indication of incident thrombus (N = 283).
Results:
Successful resolution of thrombus was directly associated with attaining a therapeutic anti-Xa concentration upon first laboratory evaluation. Other characteristics with associations to initial anti-Xa values included age, body mass index, and certain diagnoses. The rate of composite bleeding was consistent across concentrations of anti-Xa (p = 0.4944).
Conclusions:
Despite adherence to protocol, the current enoxaparin dosing nomogram is only successful at achieving a therapeutic anti-Xa concentration (0.5-1.0 unit/mL) 55.8% of the time. A more aggressive enoxaparin dosing nomogram is warranted, as delaying time to therapeutic anti-Xa values impacts clinical outcomes, specifically thrombus resolution. Further investigation into characteristics with association to anti-Xa concentrations is needed.
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