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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinically Guided Cohort | Active Comparator | Estimated Effective Warfarin dosing calculations are based on clinical data algorithms |
|
| Pharmacogenetically Guided Cohort | Experimental | Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inpatient Length of Stay | Inpatient length of stay | during hospital stay, up to 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Supratherapeutic Dosing | International Normalized Ratio | during hospital stay, up to 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David O Meltzer, MD, PhD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy. |
| FG001 | Experimental | Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Experimental |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age categories are defined as 18-39, 40-60, 61-75, and 75 years and up. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inpatient Length of Stay | Inpatient length of stay | Posted | Mean | Standard Deviation | days | during hospital stay, up to 60 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DVT or PE | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr David Meltzer | University of Chicago | 773-702-0836 | dmeltzer@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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|
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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Supratherapeutic Dosing | International Normalized Ratio | Posted | Mean | Standard Deviation | ratio | during hospital stay, up to 60 days |
|
|
|
| 0 |
| 181 |
| 7 |
| 181 |
| 0 |
| 181 |
| EG001 | Experimental | Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy. | 2 | 178 | 1 | 178 | 0 | 178 |
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| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |