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Plast Reconstr Surg Glob Open. 2019 Apr 11;7(4):e2185. doi: 10.1097/GOX.0000000000002185. eCollection 2019 Apr.

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.

Author information

1
Division of Plastic Surgery, Division of Health Services Research, University of Utah, Salt Lake City, Utah.
2
Division of Plastic Surgery, University of Utah, Salt Lake City, Utah.
3
Department of Pharmacy, University of Utah, Salt Lake City, Utah.
4
Study Design and Biostatistics Center, University of Utah, Salt Lake City, Utah.
5
Division of Plastic and Reconstructive Surgery, Stanford University, Palo Alto, Calif.

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.

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