Clinical and Economic Implications of Genetic Testing for Warfarin Management
The Hospital and Economics CERT: Project 1: The Clinical and Economic Implications of Genetic Testing for Warfarin Management
1 other identifier
interventional
359
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 12, 2009
CompletedFirst Posted
Study publicly available on registry
August 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
November 25, 2019
CompletedNovember 25, 2019
October 1, 2019
3 years
August 12, 2009
October 8, 2019
November 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inpatient Length of Stay
Inpatient length of stay
during hospital stay, up to 60 days
Secondary Outcomes (1)
Supratherapeutic Dosing
during hospital stay, up to 60 days
Study Arms (2)
Clinically Guided Cohort
ACTIVE COMPARATOREstimated Effective Warfarin dosing calculations are based on clinical data algorithms
Pharmacogenetically Guided Cohort
EXPERIMENTALEstimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.
Interventions
Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
Eligibility Criteria
You may qualify if:
- warfarin-naive patients
- ages 18 and older
- are undergoing inpatient anticoagulation initiation with warfarin for diagnoses that necessitate anticoagulation
You may not qualify if:
- patients who are not warfarin-naive
- years of age or younger
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr David Meltzer
- Organization
- University of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
David O Meltzer, MD, PhD
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2009
First Posted
August 24, 2009
Study Start
August 1, 2009
Primary Completion
August 1, 2012
Study Completion
April 1, 2014
Last Updated
November 25, 2019
Results First Posted
November 25, 2019
Record last verified: 2019-10