Genetics informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT): rationale and study design

E J Do, P Lenzini, C S Eby, A R Bass, G A McMillin, S M Stevens, S C Woller, R C Pendleton, J L Anderson, P Proctor, R M Nunley, V Davila-Roman, B F Gage, E J Do, P Lenzini, C S Eby, A R Bass, G A McMillin, S M Stevens, S C Woller, R C Pendleton, J L Anderson, P Proctor, R M Nunley, V Davila-Roman, B F Gage

Abstract

The risk of venous thromboembolism (VTE) is higher after the total hip or knee replacement surgery than after almost any other surgical procedure; warfarin sodium is commonly prescribed to reduce this peri-operative risk. Warfarin has a narrow therapeutic window with high inter-individual dose variability and can cause hemorrhage. The genetics-informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT) is a 2 × 2 factorial-design, randomized controlled trial designed to compare the safety and effectiveness of warfarin-dosing strategies. GIFT will answer two questions: (1) does pharmacogenetic (PGx) dosing reduce the rate of adverse events in orthopedic patients; and (2) is a lower target international normalized ratio (INR) non-inferior to a higher target INR in orthopedic participants? The composite primary endpoint of the trial is symptomatic and asymptomatic VTE (identified on screening ultrasonography), major hemorrhage, INR ≥ 4, and death.

Conflict of interest statement

Conflict of interest

The authors declare no conflicts of interest with this study.

Figures

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