Reliability of Point-of-care INR Measurements in Patients With Antiphospholipid-antibody Syndrome Treated With Warfarin
Public ClinicalTrials.gov record NCT00878137. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
INR Determined by Plasma-based Methods Versus Newer Point-of-care Instruments in Patients With Antiphospholipid-antibody Syndrome Treated With Anticoagulants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00878137
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2009 (Type not available)
- Primary completion
- May 2009 (Actual)
- Completion
- May 2009 (Actual)
- Last update posted
- Oct 15, 2012
2009
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00878137, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 15, 2012 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00878137 live on ClinicalTrials.gov.