Blood Coagulation Disorders
Conditions
Keywords
coumadine, genotype, genes, Warfarin
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.
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.
Interventions
DRUGWarfarin
Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inpatient Length of Stay | during hospital stay, up to 60 days | Inpatient length of stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Supratherapeutic Dosing | during hospital stay, up to 60 days | International Normalized Ratio |
Countries
United States
Participant flow
Pre-assignment details
Patients were deleted from the study due to patient delay of surgery, baseline INR being too high, patient rescheduling or canceling surgery, no INR ordered, no admission to hospital.
Participants by arm
| Arm | Count |
|---|---|
| Control Estimated Effective Warfarin dosing calculations are based on clinical data algorithms
Warfarin: Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose. | 181 |
| Experimental Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.
Warfarin: Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose. | 178 |
| Total | 359 |
Baseline characteristics
| Characteristic | Control | Experimental | Total |
|---|---|---|---|
| Age, Customized 18-39 years | 19 Participants | 20 Participants | 39 Participants |
| Age, Customized 40-60 years | 55 Participants | 75 Participants | 130 Participants |
| Age, Customized 61-75 years | 77 Participants | 60 Participants | 137 Participants |
| Age, Customized 75 years or more | 30 Participants | 23 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 7 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 171 Participants | 170 Participants | 341 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 84 Participants | 72 Participants | 156 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 10 Participants | 22 Participants |
| Race (NIH/OMB) White | 85 Participants | 93 Participants | 178 Participants |
| Region of Enrollment United States | 181 participants | 178 participants | 359 participants |
| Sex: Female, Male Female | 111 Participants | 93 Participants | 204 Participants |
| Sex: Female, Male Male | 70 Participants | 85 Participants | 155 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 181 | 2 / 178 |
| other Total, other adverse events | 0 / 181 | 0 / 178 |
| serious Total, serious adverse events | 7 / 181 | 1 / 178 |
Outcome results
Primary
Inpatient Length of Stay
Inpatient length of stay
Time frame: during hospital stay, up to 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Inpatient Length of Stay | 6.8 days | Standard Deviation 7 |
| Experimental | Inpatient Length of Stay | 7.2 days | Standard Deviation 11.2 |
Secondary
Supratherapeutic Dosing
International Normalized Ratio
Time frame: during hospital stay, up to 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Supratherapeutic Dosing | 2.2 ratio | Standard Deviation 0.2 |
| Experimental | Supratherapeutic Dosing | 2.2 ratio | Standard Deviation 0.3 |