Ignite Creation Date:
2024-05-05 @ 10:09 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01037270
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2009-12-17
Brief Title:
Evaluation of the Accuracy and Precision of the INRatio Prothrombin Time PT Monitoring System With New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity
Sponsor:
Abbott RDx Cardiometabolic
Organization:
Abbott RDx Cardiometabolic
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-02
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:
ECLIPSE-01
Brief Summary:
This is a multi-center study designed to evaluate the accuracy and precision of the INRatio Prothrombin Time PT Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity when used by trained medical professionals for the quantitative determination of PT and International Normalized Ratio INR in fingerstick and venous whole blood from subjects on oral anticoagulation therapy OAT These results will be compared to those PTINR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System
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