Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery

Completed · Phase 2

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

In brief

Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic \& reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.

Key facts

Study ID

NCT03212365

Run by

University of Utah

People needed

295

Starts

2017-07-03

Expected to finish

2019-10-01

Last updated by the study team

2020-09-16

Who can join

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

You may qualify if…

• receiving plastic and reconstructive surgery under general anesthesis
• Expected post-operative stay of 2 days or more

You may not qualify if…

• Contraindication to use of enoxaparin
• intracranial bleeding/stroke
• Hematoma or bleeding disorder
• Heparin-induced thrmbocytopenia positive
• Creatinine clearance less than or equal to 30 mL/min
• Serum creatinine greater than 1.6 mg/dL
• epidural anesthesia
• patients placed on non-enoxaparin chemoprophylaxis regimens
• gross weight exceeding 150kg

Where it is running

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

Full record on ClinicalTrials.gov

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