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Double-Blind Randomized Clinical Trial to Examine the Pharmacokinetic and Clinical Impacts of Fixed Dose versus Weight-based Enoxaparin Prophylaxis: A Methodologic Description of the FIxed or Variable Enoxaparin (FIVE) Trial. Plastic and reconstructive surgery. Global open Pannucci, C. J., Fleming, K. I., Bertolaccini, C., Prazak, A. M., Stoddard, G. J., Momeni, A. 2019; 7 (4): e2185

Abstract

Venous thromboembolism is an important patient safety in plastic surgery, and multiple clinical trials in the past 10 years have provided increased understanding of the risks and benefits of venous thromboembolism prevention strategies. This paper provides an exhaustive discussion of the rationale behind and methodology for an in progress randomized double-blind clinical trial in plastic surgery inpatients, in which the 2 study arms are enoxaparin 40?mg twice daily and enoxaparin 0.5?mg/kg twice daily. The trial's primary aims are to: (1) demonstrate whether enoxaparin 0.5?mg/kg twice daily is superior to enoxaparin 40?mg twice daily for the pharmacokinetic endpoint of overanticoagulation (anti-Factor Xa > 0.4 IU/mL) and (2) demonstrate whether enoxaparin 0.5?mg/kg twice daily is not inferior to enoxaparin 40?mg twice daily for the pharmacokinetic endpoint of underanticoagulation (anti-Factor Xa < 0.2 IU/mL). The results of this trial will provide Level I evidence to help guide plastic surgeon's choice of postoperative prophylactic anticoagulation.

View details for DOI 10.1097/GOX.0000000000002185

View details for PubMedID 31321183

View details for PubMedCentralID PMC6554177