Clinical and Economic Implications of Genetic Testing for Warfarin Management

Blood Coagulation Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964353
• Other study ID #: 16738B
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Est. completion date: April 2014

Study information

• Verified date: October 2019
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 359
• Est. completion date: April 2014
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

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

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inpatient Length of Stay	Inpatient length of stay	during hospital stay, up to 60 days
Secondary	Supratherapeutic Dosing	International Normalized Ratio	during hospital stay, up to 60 days