CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients

October 3, 2016 updated by: University of Florida

Accuracy of CoaguChek XS in Patients With Antiphospholipid Antibody Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • UF and Shands Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to UF/Shands Hematology Anticoagulation Clinic for a routine office visit with pharmacy.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1 and Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: James Taylor, PharmD, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 15, 2014

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201400096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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