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CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients

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ClinicalTrials.gov Identifier: NCT02139072
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : October 4, 2016
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment
Antiphospholipid Antibody Syndrome Device: CoaguChek XS Procedure: Standard Lab Draw

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 Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Accuracy of CoaguChek XS in Patients With Antiphospholipid Antibody Syndrome
Study Start Date : March 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to UF/Shands Hematology Anticoagulation Clinic for a routine office visit with pharmacy.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139072


Locations
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United States, Florida
UF and Shands Health
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Hoffmann-La Roche
Investigators
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Principal Investigator: James Taylor, PharmD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02139072    
Other Study ID Numbers: IRB201400096
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: January 2016
Keywords provided by University of Florida:
Anticoagulation
International normalized ratio
Warfarin
Additional relevant MeSH terms:
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Antiphospholipid Syndrome
Syndrome
Disease
 Pathologic Processes
Autoimmune Diseases
Immune System Diseases