User Performance Evaluation of the INRatio® Prothrombin Time (PT) Monitoring System With a New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity (ECLIPSE-02)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This multi-center study is designed to evaluate the ability of intended lay users (patients on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, and 2) obtain accurate results for the quantitative determination of International Normalized Ratio (INR) when self-testing using fingerstick capillary blood. Patients will be trained by their healthcare provider using the instructions for use and product labeling provided. The accuracy of the patient INR results will be assessed by comparison to the INR results obtained by the site's trained healthcare professional using the same INRatio system (from a separate fingerstick collected from the same patient at the point-of-care), and with the INR results obtained on venous plasma obtained from the same patient and analyzed at a central laboratory with the Sysmex CA-560 System INR reference method.
| Condition |
|---|
|
Oral Anticoagulation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
- Operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Plasma specimens retained for reference method comparison.
| Enrollment: | 183 |
| Study Start Date: | August 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| BSTE-0125-Original Protocol |
| BSTE-0125.a-Amended Protocol |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients will be recruited from their primary care clinic.
Inclusion Criteria:
- Adults (18 years of age or older);
- Ability to read and speak English;
- Subjects on stable oral anticoagulation therapy with warfarin (at least 3 months);
- Target INR interval between 2.0 and 4.5
- Willing and able to provide written informed consent and comply with study procedures;
Exclusion Criteria:
- Hematocrit less than 25 or greater than 55%
- Lupus or antiphospholipid syndrome (APS)
- Already participated in this study
- A current INRatio PT Monitoring System User / Patient Self Tester
Contacts and 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 | |
More Information
No publications provided
| Responsible Party: | Biosite |
| ClinicalTrials.gov Identifier: | NCT01036646 History of Changes |
| Other Study ID Numbers: | BSTE-0125 |
| Study First Received: | December 17, 2009 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Biosite:
|
Patients on stable OAT therapy for at least 3 months. |
ClinicalTrials.gov processed this record on May 16, 2013