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NCT00933738 · ClinicalTrials.gov registry record
Evaluation of the Accuracy of the INRatio Prothrombin Time (PT) Monitoring System With a New Test Strip for the Oral Anticoagulation Therapy Patient in the Presence of Heparin and Low Molecular Weight Heparin (e.g., Enoxaparin or Dalteparin)
A clinical trial, sponsored by Abbott RDx Cardiometabolic.
- Completed
- Registry status
- 150
- Enrollment target
NCT00933738: Completed study, sponsored by Abbott RDx Cardiometabolic.
NCT00933738 is a clinical trial that has completed, run by Abbott RDx Cardiometabolic. The registered enrollment target is 150 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00933738 has completed, sponsored by Abbott RDx Cardiometabolic.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
Study Summary
This is a multi-center study designed to evaluate the heparin insensitivity of the INRatio Prothrombin Time (PT) Monitoring System, utilizing an INRatio test strip additionally modified for low sample volume. The INRatio test strip is used for the quantitative determination of PT and International Normalized Ratio (INR) results in fingerstick blood from subjects on oral anticoagulation therapy (OAT) with warfarin. This study is designed to evaluate the accuracy of the modified INRatio test strip during heparin-warfarin bridge therapy with unfractionated heparin (UH) or low molecular weight heparin (LMWH), such as enoxaparin or dalteparin. These INR results will be compared to the INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the heparin-insensitive reference method: the Sysmex CA-560 System. The levels of UH or LMWH in the plasma samples will be assessed using activated partial thromboplastin time (aPTT) and anti-factor-Xa assays respectively.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-03 |
What the finished NCT00933738 record still lists
NCT00933738 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00933738 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00933738 about?
NCT00933738 is a clinical study titled "Evaluation of the Accuracy of the INRatio Prothrombin Time (PT) Monitoring System With a New Test Strip for the Oral Anticoagulation Therapy Patient in the Presence of Heparin and Low Molecular Weight Heparin (e.g., Enoxaparin or Dalteparin)". This is a multi-center study designed to evaluate the heparin insensitivity of the INRatio Prothrombin Time (PT) Monitoring System, utilizing an INRatio test strip additionally modified for low sample volume. The INRatio test strip is used for the quantitative determination of PT and International N...
What is the current status of trial NCT00933738?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2009-12. Estimated completion is 2011-03.
Who is sponsoring clinical trial NCT00933738?
This trial is sponsored by Abbott RDx Cardiometabolic, which has 14 total clinical trials registered on ClinicalTrials.gov.
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