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 (ECLIPSE-01)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Biosite

ClinicalTrials.gov Identifier:

NCT01037270

First received: December 17, 2009

Last updated: February 8, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	December 17, 2009
Last Updated Date	February 8, 2013
Start Date ^ICMJE	August 2009
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 19, 2009)	Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01037270 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	Not Provided
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 PT/INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: Plasma specimens for reference testing.
Sampling Method	Non-Probability Sample
Study Population	Approximately 210 subjects on OAT and 20 normal healthy subjects not on anticoagulation therapy will be enrolled.
Condition ^ICMJE	Pulmonary Embolism Atrial Fibrillation Deep Vein Thrombosis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	271
Completion Date	June 2010
Primary Completion Date	April 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Adults (18 years of age or older); Willing and able to provide written informed consent and comply with study procedures; Subjects on oral anticoagulation therapy. This inclusion criterion is waived for the 20 normal healthy volunteers who must NOT be on warfarin or any other anticoagulant drug. Exclusion Criteria: Hematocrit less than 25 or greater than 55%; Lupus or antiphospholipid syndrome (APS) Vulnerable populations deemed inappropriate for study by the site's principal investigator. Already participated in this study.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01037270
Other Study ID Numbers ^ICMJE	BSTE-0124
Has Data Monitoring Committee	No
Responsible Party	Biosite
Study Sponsor ^ICMJE	Biosite
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biosite
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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