Venous Thromboembolism Clinical Trial
Official title:
Real-time Anti-Factor Xa Measurements in Surgical Patients to Examine Enoxaparin Metabolism and Optimize Enoxaparin Dose
Verified date | May 2019 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 116 |
Est. completion date | October 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults, (age=18) - Patients who have had surgery with general anesthesia. - Post-operative stay will be =2 days Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah Hospitals | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Venous thromboembolism | Symptomatic 90-day VTE confirmed with imaging | 90 days | |
Secondary | Re-operative hematoma | Bleeding requiring return to the operating room within 90 days | 90 days |
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