drugset / Trial / NCT03212365

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

NCT03212365

Phase 2 Completed 295 enrolled University of Utah Stanford University · collab
RandomizedParallel-groupDouble-blindOther

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.

Timeline

Start
2017-07-03
Primary completion
2019-06-02
Completion
2019-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Enoxaparin sodium Other / unclassified 0.5 mg/kg
Subject Enoxaparin sodium Other / unclassified 40 mg