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

• Status: Completed
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: Stanford University

Criteria

Inclusion Criteria:

• receiving plastic and reconstructive surgery under general anesthesis

• Expected post-operative stay of 2 days or more

Exclusion Criteria:

• 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