An observational study in Antiphospholipid Antibody Syndrome, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-10-04.
Sponsored by University of Florida · Observational
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.
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.
121 studies on the registry are indexed under Antiphospholipid Syndrome; 51 are open to participants now.
This study's enrollment of 60 is below the median of 181 across 52 observational studies indexed under Antiphospholipid Syndrome.
Browse Antiphospholipid Syndrome studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients presenting to UF/Shands Hematology Anticoagulation Clinic for a routine office visit with pharmacy.
Exclusion Criteria:
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 · Procedure: 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 · Procedure: Standard Lab Draw
CoaguChek XS will be used to measure INR in patients with APL
Patients on warfarin for any indication other than APL will measure INR by venous lab draw
International Normalized Ratio (INR)
Compare INR obtained by CoaguChek XS to INR obtained from venous lab draw. Difference of +/- 0.5 considered significant
Time frame: Day 1 and Day 60
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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