Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 13, 2014
First Posted Date May 15, 2014
Last Update Posted Date October 4, 2016
Study Start Date March 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2014)
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 Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients
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 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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients presenting to UF/Shands Hematology Anticoagulation Clinic for a routine office visit with pharmacy.
Condition Antiphospholipid Antibody Syndrome
Intervention
  • 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
Study Groups/Cohorts
  • 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
    Interventions:
    • Device: CoaguChek XS
    • Procedure: 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
    Interventions:
    • Device: CoaguChek XS
    • Procedure: Standard Lab Draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 14, 2014)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02139072
Other Study ID Numbers IRB201400096
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Florida
Study Sponsor University of Florida
Collaborators Hoffmann-La Roche
Investigators
Principal Investigator: James Taylor, PharmD University of Florida
PRS Account University of Florida
Verification Date January 2016