Genetics informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT): rationale and study design.
Genetics informatics trial (GIFT) of warfarin to prevent deep vein thrombosis (DVT): rationale and study design.
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DOI：
10.1038/tpj.2011.18
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发表时间：
2012-10
期刊：
影响因子：
--
通讯作者：
Gage BF
中科院分区：
文献类型：
--
作者：
Do EJ;Lenzini P;Eby CS;Bass AR;McMillin GA;Stevens SM;Woller SC;Pendleton RC;Anderson JL;Proctor P;Nunley RM;Davila-Roman V;Gage BF
全髋关节或膝关节置换术后静脉血栓栓塞（VTE）的风险高于几乎任何其他外科手术;华法林钠通常用于降低围手术期风险。Warcadine的治疗窗较窄，个体间剂量变异性较高，并可能导致出血。华法林预防深静脉血栓形成（DVT）的遗传学信息学试验（GIFT）是一项2×2因子设计的随机对照试验，旨在比较华法林给药策略的安全性和有效性。GIFT将回答两个问题：（1）药物遗传学（PGx）给药是否会降低骨科患者的不良事件发生率;（2）在骨科受试者中，较低的目标国际标准化比值（INR）是否非劣效于较高的目标INR？本试验的复合主要终点为症状性和无症状性VTE（通过筛选超声检查确定）、大出血、INR ≥ 4和死亡。
The risk of venous thromboembolism (VTE) is higher after 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.
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