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NCT01036646 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by Abbott RDx Cardiometabolic.
- Completed
- Registry status
- 183
- Enrollment target
NCT01036646 is a clinical trial that has completed, run by Abbott RDx Cardiometabolic. The registered enrollment target is 183 participants.
The verdict
NCT01036646 has completed, sponsored by Abbott RDx Cardiometabolic.
- COMPLETED
- Registry status
- 183 participants
- Enrollment target
Study Summary
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01036646
The ClinicalTrials.gov registry entry for NCT01036646 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 183 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott RDx Cardiometabolic, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01036646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01036646 about?
NCT01036646 is a clinical study titled "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". 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 i...
What is the current status of trial NCT01036646?
This trial is currently completed. The enrollment target is 183 participants. The study started on 2009-08. Estimated completion is 2010-09.
Who is sponsoring clinical trial NCT01036646?
This trial is sponsored by Abbott RDx Cardiometabolic, which has 14 total clinical trials registered on ClinicalTrials.gov.
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