CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients



Status:Completed
Conditions:Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:March 2015
End Date:January 2016

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Accuracy of CoaguChek XS in Patients With Antiphospholipid Antibody Syndrome

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.

Inclusion Criteria:

- 18-65 years of age

- anticoagulated with warfarin for at least 1 month

- Diagnosis of antiphospholipid antibody syndrome for intervention arm

Exclusion Criteria:

- any type of mental disability that would hinder their ability to give informed
consent

- any terminal illness or any other condition that could interfere with study
completion, that person will be excluded.
We found this trial at
1
site
Gainesville, Florida 32610
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Gainesville, FL
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