Overview

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