CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients

Completed

• Conditions: Antiphospholipid Antibody Syndrome
• Interventions: Device: CoaguChek XS; Procedure: Standard Lab Draw

• Registration Number: NCT02139072
• Lead Sponsor: University of Florida

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-15
• Study Start: 2015-03
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 18-65 years of age
• anticoagulated with warfarin for at least 1 month
• Diagnosis of antiphospholipid antibody syndrome for intervention arm

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CoaguChek XS	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	Standard Lab Draw	INR measured by CoaguChek XS in patients with APL at visit 1 and visit 2, in addition to routine measure by standard lab draw
Standard 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
Standard Lab Draw	CoaguChek XS	INR measured by standard lab draw at visit 1 and visit 2 for non-APL patients, in addition to routine measurement by CoaguChek XS

Primary Outcome Measures

Name	Time	Method
International Normalized Ratio (INR)	Day 1 and Day 60	Compare INR obtained by CoaguChek XS to INR obtained from venous lab draw. Difference of +/- 0.5 considered significant

Trial Locations

Locations (1)

UF and Shands Health; 🇺🇸 Gainesville, Florida, United States