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Optimizing Venous Thromboembolism Prophylaxis in Burn Patients Using Enoxaparin Through PBPK Modeling
Sabiha Rahman Mim1, Venkata K Yellepeddi2,3, Francine J Azeredo1
1Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida, USA.
CPT: Pharmacometrics & Systems Pharmacology
|May 18, 2026
Summary
Standard enoxaparin dosing often fails to prevent blood clots in burn patients, especially early after injury or with augmented renal clearance. Precision dosing informed by pharmacokinetic modeling can optimize venous thromboembolism prophylaxis.
Area of Science:
- Pharmacology
- Biomedical Engineering
- Critical Care Medicine
Background:
- Burn injuries significantly alter drug metabolism and elimination, impacting the effectiveness of anticoagulants like enoxaparin.
- Current enoxaparin dosing strategies for venous thromboembolism (VTE) prophylaxis in burn patients are often inadequate due to physiological changes.
- Limited guidance exists for optimizing enoxaparin doses based on burn severity, augmented renal clearance (ARC), and body weight.
Purpose of the Study:
- To develop a physiologically based pharmacokinetic (PBPK) model for enoxaparin in burn patients.
- To evaluate enoxaparin target attainment under standard dosing across different burn severities and renal function.
- To propose individualized dosing strategies for improved VTE prophylaxis in burn survivors.
Main Methods:
- Collected real-world data from 408 burn patients, including 1288 anti-Xa concentrations.
- Developed and validated a PBPK model in healthy adults, then extrapolated to burn patients with burn-specific adjustments.
- Simulated various enoxaparin dosing regimens across burn severities and ARC, assessing model performance with AFE and AAFE.
Main Results:
- Sub-therapeutic enoxaparin exposure was most common within 0-96 hours post-burn across all severities.
- Dose escalation in obese patients (40 to 60 mg) reduced subtherapeutic exposure from 27.3% to 16.9%.
- Patients with ARC consistently showed lower anti-Xa concentrations than those with normal renal clearance (NRC) even with dose adjustments.
Conclusions:
- Standard enoxaparin dosing is frequently insufficient for VTE prophylaxis in burn patients, particularly in the early post-burn period and in those with ARC.
- Physiologically based pharmacokinetic modeling offers a pathway to precision dosing, improving VTE prophylaxis beyond traditional weight-based methods and anti-Xa monitoring.
- Individualized enoxaparin dosing strategies are crucial for effective VTE prevention in the complex physiological state of burn injury.
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