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
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Biosite
ClinicalTrials.gov Identifier: NCT01037270     History of Changes
Other Study ID Numbers: BSTE-0124
Study First Received: December 17, 2009
Last Updated: February 8, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014