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NCT00878137 · ClinicalTrials.gov registry record
Reliability of Point-of-care INR Measurements in Patients With Antiphospholipid-antibody Syndrome Treated With Warfarin
A clinical trial of Antiphospholipid Syndrome, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 63
- Enrollment target
- 1
- Study location
NCT00878137 is a study of Antiphospholipid Syndrome that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 63 participants, below the 1,440-participant average among 6 other Antiphospholipid Syndrome trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00878137, a study of Antiphospholipid Syndrome, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 63 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE INR by point-of-care instruments and venopuncture
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2009-03 |
| Est. Completion | 2009-05 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00878137
The ClinicalTrials.gov registry entry for NCT00878137 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,440-participant average among 6 other Antiphospholipid Syndrome trials with a reported enrollment target (96% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Antiphospholipid Syndrome appearing as the primary indexed condition, and to 1 intervention - of which INR by point-of-care instruments and venopuncture is the first listed.
NCT00878137 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT00878137 about?
NCT00878137 is a clinical study titled "Reliability of Point-of-care INR Measurements in Patients With Antiphospholipid-antibody Syndrome Treated With Warfarin". 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 throm...
What is the current status of trial NCT00878137?
This trial is currently completed. The enrollment target is 63 participants. The study started on 2009-03. Estimated completion is 2009-05.
What conditions does trial NCT00878137 study?
This clinical trial studies the following conditions: Antiphospholipid Syndrome.
What interventions are being tested in trial NCT00878137?
The interventions under investigation include: INR by point-of-care instruments and venopuncture (DEVICE).
Who is sponsoring clinical trial NCT00878137?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00878137 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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