The Hospital and Economics CERT: Project 1: The Clinical and Economic Implications of Genetic Testing for Warfarin Management
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 359
- 试验地点
- 1
- 主要终点
- Inpatient Length of Stay
研究概览
简要总结
The purpose of this study is to explore how knowing genes that individuals inherit from their parents can make warfarin dosing more safe and effective. This study is being done to determine whether providing doctors with data on the genes their patients inherited and warfarin dosing recommendations based on those genes affects the costs and outcomes of care and after hospitalization for patients from different ethnic/racial backgrounds, and how physicians use this information in decision making.
详细描述
The overall goal of this project is to develop and assess the effectiveness and cost-effectiveness of strategies that use genetic testing in the management of anticoagulation among racially diverse hospitalized patients. The project has four specific aims.
Aim 1: To contribute patients initiating therapy at the University of Chicago Medical Center (UCMC) and affiliated hospitals to a genetic registry of a racially diverse set of patients undergoing warfarin therapy.
Aim 2: To perform a randomized trial to determine the efficacy, costs and cost-effectiveness of existing pharmacogenetic algorithms for the management of warfarin therapy among hospitalized patients of all races.
Aim 3: To develop clinical pharmacogenetic algorithms for the management of warfarin therapy among hospitalized African American patients.
Aim 4: To perform a randomized trial to determine and compare the efficacy, costs and cost-effectiveness of existing clinical and non-racially tailored pharmacogenetic algorithms to racially tailored pharmacogenetic algorithms for the management of warfarin therapy among hospitalized African American patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •warfarin-naive patients
- •ages 18 and older
- •are undergoing inpatient anticoagulation initiation with warfarin for diagnoses that necessitate anticoagulation
排除标准
- •patients who are not warfarin-naive
- •17 years of age or younger
研究组 & 干预措施
Pharmacogenetically Guided Cohort
Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.
干预措施: Warfarin (Drug)
Clinically Guided Cohort
Estimated Effective Warfarin dosing calculations are based on clinical data algorithms
干预措施: Warfarin (Drug)
结局指标
主要结局
Inpatient Length of Stay
时间窗: during hospital stay, up to 60 days
Inpatient length of stay
次要结局
- Supratherapeutic Dosing(during hospital stay, up to 60 days)