CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients

University of Florida

Status: Completed

Conditions: Antiphospholipid Antibody Syndrome

Treatments: Procedure: Standard Lab Draw; Device: CoaguChek XS

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02139072

IRB201400096

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

CoaguChek XS

Description:

INR measured by CoaguChek XS in patients with APL at visit 1 and visit 2, in addition to routine measure by standard lab draw

Treatment:

Device: CoaguChek XS

Procedure: Standard Lab Draw

Standard Lab Draw

Description:

INR measured by standard lab draw at visit 1 and visit 2 for non-APL patients, in addition to routine measurement by CoaguChek XS

Treatment:

Device: CoaguChek XS

Procedure: Standard Lab Draw