Clinical and Economic Implications of Genetic Testing for Warfarin Management
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Blood Coagulation Disorders |
Drug: Warfarin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | The Hospital and Economics CERT: Project 1: The Clinical and Economic Implications of Genetic Testing for Warfarin Management |
- Clinical outcomes and costs associated with the use of genetic testing will be compared to current standards of care and alternative management practices to assess the value of genotype-guided warfarin therapy algorithms for patients and payers. [ Time Frame: 30 days after discharge ] [ Designated as safety issue: Yes ]
- Clinical outcomes: inpatient length of stay, supratherapeutic dosing, time within range, and the incidence of deep venous thrombosis (DVT), stroke, pulmonary embolus (PE), gastrointestinal bleeding (GI) and intracranial hemorrhage (ICH). [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Direct costs of interest include: hospital costs, genetic costs, medication costs, laboratory costs, and total therapy costs in aggregate and broken down by payer. [ Time Frame: 1 month after discharge ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 268 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | December 2014 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: Coumadin
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00964353
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: | David O Meltzer, MD, PhD | University of Chicago |
More Information
No publications provided
| Responsible Party: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00964353 History of Changes |
| Other Study ID Numbers: | 16738B |
| Study First Received: | August 12, 2009 |
| Last Updated: | May 22, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
coumadine genotype genes Warfarin |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Cardiovascular Diseases Hematologic Diseases Hemorrhagic Disorders Vascular Diseases |
Warfarin Anticoagulants Hematologic Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015