Venous Thromboembolism Clinical Trial
Official title:
Optimization of Enoxaparin Prophylaxis Using Real-time Anti-Factor Xa Levels in Major Reconstructive Surgery Patients
NCT number | NCT02687204 |
Other study ID # | 86052 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | December 6, 2017 |
Verified date | October 2018 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Blood clots that form in the extremities (deep venous thrombosis) and lungs (pulmonary
embolus) are feared complications of reconstructive surgery. One in ten patients with
symptomatic pulmonary embolus will be dead in 60 minutes. Patients with deep venous
thrombosis can develop the post-thrombotic syndrome, known to be a major driver of poor
quality of life. These phenomena, broadly known as venous thromboembolism (VTE), have
substantial downstream ramifications, and the US Surgeon General and the American Society of
Plastic Surgeons (ASPS), among others, have underscored the importance of VTE prevention in
surgical patients. Reconstructive surgery, most commonly performed to fix traumatic injuries
or defects after cancer excision, often involves borrowing tissue from adjacent or distant
areas on the body; reconstructive surgery patients can routinely have surgical injury
involving 20% or more of their total body surface area. Injury and resultant inflammation are
known to increase metabolism of certain drugs, including those used to prevent VTE after
surgery.
Enoxaparin is a blood-thinning medication that decreases likelihood of blood clot formation.
Previous research has shown that reconstructive surgery patients who are given enoxaparin
after surgery are less likely to develop VTE. However, despite receiving of a standard dose
of enoxaparin, many patients still develop this life-threatening complication. The
investigators believe that patients metabolize enoxaparin differently based on the degree of
surgical injury created during reconstruction, and seek to critically examine enoxaparin
metabolism in reconstructive surgery patients. The proposed research will evaluate how
enoxaparin affects the blood based on standard, ASPS-recommended dosing after reconstructive
surgeries; the investigators will also examine whether the extent of surgical injury alters
metabolism as well. Enoxaparin effectiveness will be tracked using anti-Factor Xa (aFXa)
levels. If subtherapeutic aFXa levels are observed, the study will also design, implement and
test a clinical enoxaparin dose-adjustment protocol to achieve appropriate post-operative
aFXa levels. Further research based on these data will examine reduction in VTE risk when
aFXa-driven enoxaparin dosing is used.
Status | Completed |
Enrollment | 118 |
Est. completion date | December 6, 2017 |
Est. primary completion date | June 23, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - Adult patients having plastic and reconstructive surgery who are placed on twice daily enoxaparin prophylaxis after surgery. Exclusion criteria: - 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 - Epidural anesthesia. |
Country | Name | City | State |
---|---|---|---|
United States | University of Utah Hospitals | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | Agency for Healthcare Research and Quality (AHRQ) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with a 90-day VTE (either a 90-day DVT or 90-day PE) | Outcome measure number one will be deep venous thrombosis or pulmonary embolus confirmed with imaging within 90 days of the initial surgery. | 90 days | |
Secondary | Number of patients with a 90-day re-operative hematoma | Outcome number two will be bleeding (hematoma) requiring return to the operating room within 90 days of the initial operation. | 90 days |
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