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NCT01037270 · ClinicalTrials.gov registry record
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
A clinical trial of Atrial Fibrillation and Pulmonary Embolism, sponsored by Abbott RDx Cardiometabolic.
- Completed
- Registry status
- 271
- Enrollment target
- 4
- Study locations
NCT01037270: Completed study of Atrial Fibrillation and Pulmonary Embolism, sponsored by Abbott RDx Cardiometabolic.
NCT01037270 is a study of Atrial Fibrillation and Pulmonary Embolism that has completed, run by Abbott RDx Cardiometabolic. The registered enrollment target is 271 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01037270, a study of Atrial Fibrillation and Pulmonary Embolism, has completed, sponsored by Abbott RDx Cardiometabolic.
- COMPLETED
- Registry status
- 271 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Conditions Studied
Study Locations (4)
California
- Loma Linda VA Hospital - Loma Linda
- UC Davis Healthcare System - Sacramento
- San Diego Cardiac Center - San Diego
Illinois
- Fox Valley Cardiology - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 271 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-06 |
What the finished NCT01037270 record still lists
NCT01037270 is an observational study that tracks outcomes without assigning an intervention. The registered 271 participants enrollment target is mid-sized for trials with a published cap, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 0 interventions.
NCT01037270 reports a single indexed study location in California, Illinois.
Frequently Asked Questions
What is clinical trial NCT01037270 about?
NCT01037270 is a clinical study titled "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". 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 deter...
What is the current status of trial NCT01037270?
This trial is currently completed. The enrollment target is 271 participants. The study started on 2009-08. Estimated completion is 2010-06.
What conditions does trial NCT01037270 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Pulmonary Embolism, Deep Vein Thrombosis.
Who is sponsoring clinical trial NCT01037270?
This trial is sponsored by Abbott RDx Cardiometabolic, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01037270 being conducted?
This trial has 4 study locations across California, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01037270's enrollment target sits among peer trials
271 86th of 202 higher than 117 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
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