Real-time Anti-Factor Xa Measurements in Surgical Patients to Examine Enoxaparin Metabolism and Optimize Enoxaparin Dose

Completed · Early Phase 1

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

In brief

Venous thromboembolism (VTE) encompasses deep venous thrombosis and pulmonary embolus, and is the proximate cause of death in over 100,000 hospitalized patients per year. This project will critically examine the pharmacokinetics of prophylactic doses of enoxaparin in surgical patients, and will evaluate how alteration of enoxaparin dose magnitude and frequency affects peak and trough aFXa levels as well as risk for re-operative hematoma. If subtherapeutic aFXa levels are observed, the study will design, implement and test a clinical protocol to optimize post-operative aFXa levels. Although not an explicit Aim, this study will also provide important preliminary data on VTE rates in surgical patients with in range and out of range aFXa levels.

Key facts

Study ID: NCT02704052
Run by: University of Utah
People needed: 116
Starts: 2016-03-01
Expected to finish: 2018-10-01
Last updated by the study team: 2019-05-24

Who can join

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

You may qualify if…

Adults, (age≥18)
Patients who have had surgery with general anesthesia.
Post-operative stay will be ≥2 days

You may not qualify if…

Contradiction to use enoxaparin
History of intracranial bleeding/stroke, hematoma or bleeding disorder, heparin-induced thrombocytopenia positive, and heparin-induced thrombocytopenia positive
Creatinine clearance ≤ 30mL/min
Serum creatinine >1.6mg/dL
Epidural anesthesia
Patients placed on non-enoxaparin chemoprophylaxis regimens per their surgeon's discretion.

Where it is running

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

Full record on ClinicalTrials.gov

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