Reliability of Point-of-care INR Measurements in Patients With Antiphospholipid-antibody Syndrome Treated With Warfarin
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ClinicalTrials.gov Identifier: NCT00878137 |
Recruitment Status
:
Completed
First Posted
: April 8, 2009
Last Update Posted
: October 15, 2012
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Condition or disease | Intervention/treatment |
---|---|
Antiphospholipid Syndrome | Device: INR by point-of-care instruments and venopuncture |
Study Type : | Observational |
Actual Enrollment : | 63 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | INR Determined by Plasma-based Methods Versus Newer Point-of-care Instruments in Patients With Antiphospholipid-antibody Syndrome Treated With Anticoagulants |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | May 2009 |

Group/Cohort | Intervention/treatment |
---|---|
APLA
Patients with antiphospholipid antibody syndrome.
|
Device: INR by point-of-care instruments and venopuncture
Three fingersticks will be performed and from each one drop of capillary or venous whole blood collected from a fingerstick performed by the primary investigator to measure PT/INR using the CoaguChekXSTM (10 microliters), ProTimeTM (27 microliters), the investigational ProTime, and INRatioTM 15 microliters) point-of-care instruments and one i.v. blood draw (20 mL of blood) will be performed by a phlebotomist.
|
Control
Patients on warfarin therapy but without antiphosphilipid antibody syndrome.
|
Device: INR by point-of-care instruments and venopuncture
Three fingersticks will be performed and from each one drop of capillary or venous whole blood collected from a fingerstick performed by the primary investigator to measure PT/INR using the CoaguChekXSTM (10 microliters), ProTimeTM (27 microliters), the investigational ProTime, and INRatioTM 15 microliters) point-of-care instruments and one i.v. blood draw (20 mL of blood) will be performed by a phlebotomist.
|

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
APLA Inclusion Criteria:
- Prolongation of a phospholipid-dependent screening assay, 2) lack of correction of a prolonged screening assay after a 1:1 mix with pooled normal plasma, and 3) correction of a prolonged screening assay by the addition of excess phospholipid. Two positive lupus anticoagulant confirmations at least 3 months apart will be required.
- Diagnosis of anticardiolipin antibodies defined as elevated levels of ACA-IgG (>30) and/or ACA-IgM (>15) on two separate occasions at least 3 months apart.
- Stable warfarin therapy, defined as the maintenance of a warfarin dose for a minimal of 2 weeks regardless of INR.
APLA Exclusion Criteria:
- Patients whose warfarin dose has changed within the past 2 weeks.
Control Inclusion Criteria:
- No evidence of either a positive LA or ACA diagnosis by confirmation of negative laboratory values and/or documentation of no clinical signs and symptoms concurrent with these conditions.
- Stable warfarin therapy, defined as the maintenance of a warfarin dose for a minimal of 2 weeks regardless of INR.
Control Exclusion Criteria:
- Patients whose warfarin dose has changed within the past 2 weeks.

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): NCT00878137
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27514 |
Principal Investigator: | Lauren B McKnight, PharmD | University of North Carolina, Chapel Hill |
Responsible Party: | Lauren McKnight, PharmD, CPP, Clinical Pharmacist, University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00878137 History of Changes |
Other Study ID Numbers: |
POC Comparison 08-1883 |
First Posted: | April 8, 2009 Key Record Dates |
Last Update Posted: | October 15, 2012 |
Last Verified: | October 2012 |
Additional relevant MeSH terms:
Syndrome Antiphospholipid Syndrome Antibodies, Antiphospholipid Disease Pathologic Processes Autoimmune Diseases Immune System Diseases |
Antibodies Immunoglobulins Warfarin Immunologic Factors Physiological Effects of Drugs Anticoagulants |