Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood
This study has been completed.
Sponsor:
Universal Biosensors Pty Ltd
Information provided by:
Universal Biosensors Pty Ltd
ClinicalTrials.gov Identifier:
NCT01375725
First received: June 15, 2011
Last updated: June 16, 2011
Last verified: June 2011
| Tracking Information | |||||
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| First Received Date ICMJE | June 15, 2011 | ||||
| Last Updated Date | June 16, 2011 | ||||
| Start Date ICMJE | September 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
PT/INR values from the experimental device will be statistically correlated to results obtained from a commercially available device [ Time Frame: Five days to collect data and up to two weeks to generate correlation graph ] [ Designated as safety issue: No ] To determine the correlation of PT/INR values between an experimental and commercial device |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01375725 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood | ||||
| Official Title ICMJE | Mobius PT-INR Accuracy Clinical Study | ||||
| Brief Summary | The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available device. This study will involve taking a finger-puncture and testing onto a strip and meter system for the experimental and commercially available devices. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Subjects currently receiving coumadin (warfarin) treatment |
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| Condition ICMJE | Clotting Disorders | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Coumadin (warfarin)
Subjects currently receiving coumadin (warfarin) treatment. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01375725 | ||||
| Other Study ID Numbers ICMJE | MOB 0046 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Richard Ward, Assistant Professor, College of Pharmacy Harding University | ||||
| Study Sponsor ICMJE | Universal Biosensors Pty Ltd | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Universal Biosensors Pty Ltd | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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