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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:
ClinicalTrials.gov Identifier:
NCT01037270
First Posted: December 22, 2009
Last Update Posted: February 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biosite
  Purpose
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.

Condition
Pulmonary Embolism Atrial Fibrillation Deep Vein Thrombosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Biosite:

Primary Outcome Measures:
  • Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System. [ Time Frame: 3-6 months ]

Biospecimen Retention:   Samples Without DNA
Plasma specimens for reference testing.

Enrollment: 271
Study Start Date: August 2009
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Approximately 210 subjects on OAT and 20 normal healthy subjects not on anticoagulation therapy will be enrolled.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037270


Locations
United States, California
Loma Linda VA Hospital
Loma Linda, California, United States, 92357
UC Davis Healthcare System
Sacramento, California, United States, 95817
San Diego Cardiac Center
San Diego, California, United States, 92123
United States, Illinois
Fox Valley Cardiology
Aurora, Illinois, United States, 60504
Sponsors and Collaborators
Biosite
  More Information

Responsible Party: Biosite
ClinicalTrials.gov Identifier: NCT01037270     History of Changes
Other Study ID Numbers: BSTE-0124
First Submitted: December 17, 2009
First Posted: December 22, 2009
Last Update Posted: February 11, 2013
Last Verified: February 2013

Keywords provided by Biosite:
Patients with conditions (PE, Afib, DVT) requiring ongoing INR measurements.

Additional relevant MeSH terms:
Atrial Fibrillation
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases