CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Antiphospholipid Antibody Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

CoaguChek XS

Intervention Type DEVICE

CoaguChek XS will be used to measure INR in patients with APL

Standard Lab Draw

Intervention Type PROCEDURE

Patients on warfarin for any indication other than APL will measure INR by venous 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

CoaguChek XS

Intervention Type DEVICE

CoaguChek XS will be used to measure INR in patients with APL

Standard Lab Draw

Intervention Type PROCEDURE

Patients on warfarin for any indication other than APL will measure INR by venous lab draw

Interventions

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CoaguChek XS

CoaguChek XS will be used to measure INR in patients with APL

Intervention Type DEVICE

Standard Lab Draw

Patients on warfarin for any indication other than APL will measure INR by venous lab draw

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No