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Completed

NCT Number: NCT00964353

Clinical and Economic Implications of Genetic Testing for Warfarin Management

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.

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Key information

Conditions

Blood Coagulation Disorders Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • warfarin-naive patients
  • ages 18 and older
  • are undergoing inpatient anticoagulation initiation with warfarin for diagnoses that necessitate anticoagulation

Exclusion criteria

  • patients who are not warfarin-naive
  • 17 years of age or younger

Treatment and study plan

Warfarin

Drug

Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.

Other names: Coumadin

Primary outcomes

  1. Inpatient Length of Stay

    Time frame: during hospital stay, up to 60 days

    Inpatient length of stay

Secondary outcomes

  1. Supratherapeutic Dosing

    Time frame: during hospital stay, up to 60 days

    International Normalized Ratio

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

The Hospital and Economics CERT: Project 1: The Clinical and Economic Implications of Genetic Testing for Warfarin Management

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Aug 24, 2009
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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