Objectives: To determine the feasibility and impact of real-time anti-factor Xa (aFXa) level monitoring and enoxaparin dose adjustment in orthopaedic trauma. To examine the adequacy of standard fixed-dose enoxaparin chemoprophylaxis and to examine whether patient-specific factors influence enoxaparin metabolism.
Design: Prospective cohort.
Setting: Academic Level-I trauma center.
Patients: Postoperative adult orthopaedic trauma patients undergoing acute fracture or nonunion surgery of the pelvis, acetabulum, or lower extremity placed on 30 mg of enoxaparin twice daily.
Intervention: Peak steady-state aFXa levels were drawn with a goal range of 0.2-0.4 IU/mL. Patients with out-of-range levels underwent a 10-mg dose adjustment followed by repeat aFXa draws.
Main outcome measures: Peak and trough aFXa levels, 90-day venous thromboembolism, and bleed events.
Results: Of 109 enrolled patients, 43% had inadequate initial peak aFXa levels (aFXa < 0.2 IU/mL) with standard dosing. Higher gross weight, acetabular surgery, and operation length predicted low aFXa levels (P < 0.001, 0.006, 0.004, respectively). Dose adjustment increased the proportion of patients with in-range aFXa levels from 53.2% to 87.8% (P < 0.001). Patients with low aFXa levels during hospitalization or at discharge had significantly higher 90-day deep vein thrombosis and pulmonary embolism rates compared to those with adequate aFXa levels (deep vein thrombosis 12% vs. 1.36%; P = 0.023, pulmonary embolism 8% vs. 0%; P = 0.027). There were no major bleed events.
Conclusions: Patients receiving inadequate enoxaparin chemoprophylaxis were at significantly increased risk of 90-day venous thromboembolism. Standard fixed-dose enoxaparin provided inadequate chemoprophylaxis in 43% of postoperative orthopaedic trauma patients, which significantly improved with dose adjustment. Weight, acetabular surgery, and operation length predicted inadequate enoxaparin prophylaxis.
Level of evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.