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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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The purpose of this study is to see if the CoaguChek XS is accurate in measuring International Normalized Ratio (INR) in patients with Antiphospholipid Antibody Syndrome (APL) receiving warfarin therapy.
Antiphospholipid Antibody Syndrome (APL) is an autoimmune disease that increases ones risk for blood clots. Therefore, these patients receive anticoagulation therapy with warfarin. Point of care devices such as the CoaguChek XS are often used to monitor International Normalized Ratio (INR) in patients on warfarin. However, the antibodies present in patients with APL may lead to false INR results when using the CoaguChek XS. This study will compare the accuracy of the CoaguChek XS in measuring INR in patients with APL by measuring INR by the CoaguChek XS and a standard lab as a reference point. Patients on warfarin for indications other than APL will be measured by both methods as well to serve as a control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoaguChek XS | INR measured by CoaguChek XS in patients with APL at visit 1 and visit 2, in addition to routine measure by standard lab draw |
| |
| Standard Lab Draw | INR measured by standard lab draw at visit 1 and visit 2 for non-APL patients, in addition to routine measurement by CoaguChek XS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoaguChek XS | Device | CoaguChek XS will be used to measure INR in patients with APL |
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| Measure | Description | Time Frame |
|---|---|---|
| International Normalized Ratio (INR) | Compare INR obtained by CoaguChek XS to INR obtained from venous lab draw. Difference of +/- 0.5 considered significant | Day 1 and Day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting to UF/Shands Hematology Anticoagulation Clinic for a routine office visit with pharmacy.
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| Name | Affiliation | Role |
|---|---|---|
| James Taylor, PharmD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF and Shands Health | Gainesville | Florida | 32610 | United States |
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| ID | Term |
|---|---|
| D016736 | Antiphospholipid Syndrome |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Standard Lab Draw | Procedure | Patients on warfarin for any indication other than APL will measure INR by venous lab draw |
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