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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

December 17, 2009
February 8, 2013
August 2009
April 2010   (final data collection date for primary outcome measure)
Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01037270 on ClinicalTrials.gov Archive Site
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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
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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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Plasma specimens for reference testing.

Non-Probability Sample

Approximately 210 subjects on OAT and 20 normal healthy subjects not on anticoagulation therapy will be enrolled.

  • Pulmonary Embolism
  • Atrial Fibrillation
  • Deep Vein Thrombosis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
271
June 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01037270
BSTE-0124
No
Biosite
Biosite
Not Provided
Not Provided
Biosite
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP