Ignite Creation Date:
2024-05-05 @ 9:22 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00878137
Status:
COMPLETED
Last Update Posted:
2012-10-15
First Post:
2009-04-06
Brief Title:
Reliability of Point-of-care INR Measurements in Patients With Antiphospholipid-antibody Syndrome Treated With Warfarin
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
INR Determined by Plasma-based Methods Versus Newer Point-of-care Instruments in Patients With Antiphospholipid-antibody Syndrome Treated With Anticoagulants
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 13 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None