Enoxaparin Metabolism in Reconstructive Surgery Patients

Completed · Phase 2

Conditions studied: Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolus, Reconstructive Surgery

In brief

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.

Key facts

Study ID

NCT02411292

Run by

University of Utah

People needed

110

Starts

2015-03-01

Expected to finish

2016-06-01

Last updated by the study team

2018-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion criteria will include:
• adult (age ≥18) patients presenting for reconstructive surgery under general anesthesia.
• expected post-operative stay will be at least three days to allow peak aFXa levels to be drawn.
• eligible patients will include those having major reconstructive surgery.

You may not qualify if…

• Exclusion criteria will include:
• contraindication to use of enoxaparin,
• intracranial bleeding/stroke,
• hematoma or bleeding disorder,
• known heparin-induced thrombocytopenia,
• creatinine clearance ≤30mL/min,
• serum creatinine >1.6mg/dL, or epidural anesthesia.

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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