Enoxaparin Metabolism in Reconstructive Surgery Patients
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
Venous thromboembolism (VTE) is a leading cause of death among hospitalized patients, and is
an important patient safety issue in plastic surgery. Previous work has shown that enoxaparin
prophylaxis can prevent many post-operative VTE events, and current American Society of
Plastic Surgeons guidelines support enoxaparin prophylaxis for high-risk patients. Highest
risk patients often have cancer or trauma reconstruction. Primary outcomes include 1) peak
and trough steady-state aFXa levels in response to standard and escalated doses of enoxaparin
and 2) the proportion of patients with appropriate aFXa levels pre and post initiation of a
clinical protocol for enoxaparin dose adjustment. The investigators expect that standard
dosing will result in inadequate aFXa peak and trough levels, and that the clinical dose
adjustment protocol will significantly improve the proportion of in-range aFXa levels. The
investigators will also develop a linear regression-based equation to calculate, based on
patient-level factors, the required dose of enoxaparin to generate in-range aFXa levels. This
research may show that the current "one size fits all" approach to enoxaparin prophylaxis is
insufficient. In the trauma and orthopaedic populations, patients with low initial aFXa
levels are significantly more likely to develop deep venous thrombosis. Thus, this study has
important implications for appropriate enoxaparin dose magnitude and frequency, and may
ultimately help to decrease the substantial morbidity and mortality associated with
post-operative VTE.