Clinical and Economic Implications of Genetic Testing for Warfarin Management

November 6, 2019 updated by: University of Chicago

The Hospital and Economics CERT: Project 1: The 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

359

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clinically Guided Cohort
Estimated Effective Warfarin dosing calculations are based on clinical data algorithms
Drug: Warfarin
Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
Other Names:
  • Coumadin
Experimental: Pharmacogenetically Guided Cohort
Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.
Drug: Warfarin
Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
Other Names:
  • Coumadin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inpatient Length of Stay
Time Frame: during hospital stay, up to 60 days
Inpatient length of stay
during hospital stay, up to 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Supratherapeutic Dosing
Time Frame: during hospital stay, up to 60 days
International Normalized Ratio
during hospital stay, up to 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: David O Meltzer, MD, PhD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

August 12, 2009

First Submitted That Met QC Criteria

August 21, 2009

First Posted (Estimate)

August 24, 2009

Study Record Updates

Last Update Posted (Actual)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16738B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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