NCT02139072

CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients

Accuracy of CoaguChek XS in Patients With Antiphospholipid Antibody Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Antiphospholipid Antibody Syndrome

Interventions

Type	Name	Description
DEVICE	CoaguChek XS	CoaguChek XS will be used to measure INR in patients with APL
PROCEDURE	Standard Lab Draw	Patients on warfarin for any indication other than APL will measure INR by venous lab draw

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-05-15
• Last updated: 2016-10-04

Locations

1 site across 1 country: United States