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Completed

NCT Number: NCT02139072

CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients

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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Key information

Conditions

Antiphospholipid Antibody Syndrome Antiphospholipid Syndrome Autoimmune Diseases Immune System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF and Shands Health

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CoaguChek XS

Device

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

Standard Lab Draw

Procedure

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

Accuracy of CoaguChek XS in Patients With Antiphospholipid Antibody Syndrome

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 15, 2014
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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