Reliability of Point-of-care INR Measurements in Patients With Antiphospholipid-antibody Syndrome Treated With Warfarin

NCT ID: NCT00878137

Last Updated: 2012-10-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-05-31

Brief Summary

The antiphospholipid-antibody syndrome (APLA), which includes lupus anticoagulant, anticardiolipin, and anti-beta-2-glycoproteinI antibodies, is a thrombophilic disorder associated with arterial thrombosis, venous thrombosis or both. Patients diagnosed with APLA have a higher risk of recurrent thrombosis than do patients without known antibodies. Currently, warfarin is considered the anticoagulant of choice for prophylactic antithrombotic treatment for APLA patients after their first episode of thrombosis. In some patients with APLA who are treated with warfarin, the INR values determined on plasma are unreliable due to an influence of the APLA on the INR. In these individuals, alternative monitoring methods, such as factor II activity, chromogenic factor X activity or prothrombin-proconvertin time should be used to assess adequate anticoagulation. These tests are expensive and not widely available to some clinicians. Point-of-care (POC) instruments, on the other hand, are readily accessible to clinicians. Previous research has shown that INR values from 3 older point-of-care (POC) instruments are unreliable in 1/3 of APLA patients (CoaguChekTM, ProTimeTM, INRatioTM). However, there are now newer versions of these POC instruments available (CoaguChek XSTM, an investigational ProTime device, and a newer INRatioTM device) and it is unknown if these newer POC instruments are reliable in patients with APLA. The purpose of this study is to determine whether newer POC instruments are reliable in patients with APLA.

Conditions

Antiphospholipid Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

APLA

Patients with antiphospholipid antibody syndrome.

INR by point-of-care instruments and venopuncture

Intervention Type: DEVICE

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.

INR by point-of-care instruments and venopuncture

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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.

Exclusion Criteria

• Patients whose warfarin dose has changed within the past 2 weeks.

• Patients whose warfarin dose has changed within the past 2 weeks.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Technidyne Corporation

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Lauren McKnight, PharmD, CPP

Clinical Pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren B McKnight, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

POC Comparison 08-1883

Identifier Type: -

Identifier Source: org_study_id