Clinical Trial: CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Accuracy of CoaguChek XS in Patients With Antiphospholipid Antibody Syndrome

Brief 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 Summary: 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.
Sponsor: University of Florida

Current Primary Outcome: International Normalized Ratio (INR) [ Time Frame: Day 1 and Day 60 ]

Compare INR obtained by CoaguChek XS to INR obtained from venous lab draw. Difference of +/- 0.5 considered significant


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Florida

Dates:
Date Received: May 13, 2014
Date Started: March 2015
Date Completion:
Last Updated: October 3, 2016
Last Verified: January 2016